ZonedIn Contact Lenses
Silicone hydrogel Daily wear soft contact lens trial +3.25 power (blisters)
5manufacturers in China registered for this device type
201catalogue numbers in this listing
Who Else Makes It
Concentrated in Hong Kong (2), Guangdong (2), Hunan (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Objectt Optik Company Limited | Hong Kong | Hong Kong | Contract manufacturer | 8 |
| Bloom MAX Limited | Central | Hong Kong | Manufacturer | 3 |
| Hunan Haipuming Technology Co., Ltd. | Shaoyang | Hunan | Manufacturer | 2 |
| Shenzhen Dashicheng Optical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
| Shenzhen Lensgoo Vision Co., Ltd. | Shenzhen | Guangdong | Repacker / relabeller | 1 |
Record
| Listed by | Zonedin Vision LLC, United States |
|---|---|
| FDA product code | LPL |
| Device type | Lenses, Soft Contact, Daily Wear |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5925 |
| Establishment | Repacker / relabeller |
| 510(k) | K083288 |
| Record published | 2020-03-03 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date, serial number |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| HD0500BO | 6 | In distribution | |
| 610175 | 6 | In distribution | |
| 600125 | 6 | In distribution | |
| SH1325BL | In distribution | ||
| SH0500BO | 6 | In distribution | |
| 610425 | 6 | In distribution | |
| 611000 | 6 | In distribution | |
| SH0325BL | In distribution | ||
| SH0700BO | 6 | In distribution | |
| SH0650BL | In distribution | ||
| 410850 | In distribution | ||
| SH0850BO | 6 | In distribution | |
| HD0325BO | 6 | In distribution | |
| SH0850BL | In distribution | ||
| HD1250BO | 6 | In distribution | |
| SH0300BL | In distribution | ||
| HD1300BO | 6 | In distribution | |
| SH0200BO | 6 | In distribution | |
| HD0050BL | In distribution | ||
| SH1225BO | 6 | In distribution | |
| 710800 | 30 | In distribution | |
| 410175 | In distribution | ||
| SH0150BL | In distribution | ||
| SH1400BL | In distribution | ||
| SH0350BO | 6 | In distribution | |
| 511000 | In distribution | ||
| HD1325BL | In distribution | ||
| 600250 | 6 | In distribution | |
| SH1600BL | In distribution | ||
| SH0200BL | In distribution | ||
| HD0550BO | 6 | In distribution | |
| 410600 | In distribution | ||
| 510125 | In distribution | ||
| HD1200BL | In distribution | ||
| 710375 | 30 | In distribution | |
| 610100 | 6 | In distribution | |
| SH0225BO | 6 | In distribution | |
| SH1600BO | 6 | In distribution | |
| 510050 | In distribution | ||
| 610700 | 6 | In distribution | |
| 510750 | In distribution | ||
| HD1375BL | In distribution | ||
| HD0125BL | In distribution | ||
| 600300 | 6 | In distribution | |
| HD0750BO | 6 | In distribution | |
| HD0250BO | 6 | In distribution | |
| SH0650BO | 6 | In distribution | |
| 410400 | In distribution | ||
| SH1250BL | In distribution | ||
| HD1150BL | In distribution | ||
| 600075 | 6 | In distribution | |
| HD0325BL | In distribution | ||
| 600275 | 6 | In distribution | |
| 600150 | 6 | In distribution | |
| 500150 | In distribution | ||
| SH1350BO | 6 | In distribution | |
| HD0575BL | In distribution | ||
| 700325 | 30 | In distribution | |
| SH0325BO | 6 | In distribution | |
| HD0375BL | In distribution | ||
| SH0900BL | In distribution | ||
| HD1200BO | 6 | In distribution | |
| 510575 | In distribution | ||
| 600200 | 6 | In distribution | |
| 511100 | In distribution | ||
| 710750 | 30 | In distribution | |
| 400125 | In distribution | ||
| HD0050BO | 6 | In distribution | |
| 710275 | 30 | In distribution | |
| 700375 | 30 | In distribution | |
| 700600 | 30 | In distribution | |
| 710500 | 30 | In distribution | |
| 600050 | 6 | In distribution | |
| 410275 | In distribution | ||
| 410375 | In distribution | ||
| SH0600BO | 6 | In distribution | |
| 611200 | 6 | In distribution | |
| 700300 | 30 | In distribution | |
| HD0450BL | In distribution | ||
| 610125 | 6 | In distribution | |
| SH0075BO | 6 | In distribution | |
| HD1325BO | 6 | In distribution | |
| 711000 | 30 | In distribution | |
| SH1050BL | In distribution | ||
| 710050 | 30 | In distribution | |
| 600100 | 6 | In distribution | |
| SH0575BO | 6 | In distribution | |
| 600350 | 6 | In distribution | |
| 410650 | In distribution | ||
| 611050 | 6 | In distribution | |
| HD0475BO | 6 | In distribution | |
| 411000 | In distribution | ||
| 400050 | In distribution | ||
| HD0425BO | 6 | In distribution | |
| SH1275BL | In distribution | ||
| SH0450BO | 6 | In distribution | |
| SH0950BO | 6 | In distribution | |
| 610225 | 6 | In distribution | |
| 410350 | In distribution | ||
| HD1225BL | In distribution | ||
| 411050 | In distribution | ||
| 710450 | 30 | In distribution | |
| 710325 | 30 | In distribution | |
| 710850 | 30 | In distribution | |
| 500250 | In distribution | ||
| HD0350BO | 6 | In distribution | |
| SH0600BL | In distribution | ||
| HD0950BO | 6 | In distribution | |
| HD0950BL | In distribution | ||
| 400200 | In distribution | ||
| SH0800BO | 6 | In distribution | |
| SH0450BL | In distribution | ||
| 400300 | In distribution | ||
| 511150 | In distribution | ||
| 610050 | 6 | In distribution | |
| SH1075BO | 6 | In distribution | |
| HD0525BL | In distribution | ||
| HD1225BO | 6 | In distribution | |
| 411200 | In distribution | ||
| HD0900BL | In distribution | ||
| 610325 | 6 | In distribution | |
| 700050 | 30 | In distribution | |
| 710100 | 30 | In distribution | |
| HD1175BL | In distribution | ||
| HD1550BO | 6 | In distribution | |
| 410500 | In distribution | ||
| 610475 | 6 | In distribution | |
| 700250 | 30 | In distribution | |
| 500175 | In distribution | ||
| 710950 | 30 | In distribution | |
| 400450 | In distribution | ||
| 610575 | 6 | In distribution | |
| 410150 | In distribution | ||
| 400100 | In distribution | ||
| SH1150BO | 6 | In distribution | |
| 610900 | 6 | In distribution | |
| HD1300BL | In distribution | ||
| HD0650BL | In distribution | ||
| 710525 | 30 | In distribution | |
| 600550 | 6 | In distribution | |
| SH1500BL | In distribution | ||
| 600500 | 6 | In distribution | |
| SH1350BL | In distribution | ||
| 400175 | In distribution | ||
| 510850 | In distribution | ||
| HD0700BO | 6 | In distribution | |
| HD0175BO | 6 | In distribution | |
| 500050 | In distribution | ||
| SH0150BO | 6 | In distribution | |
| HD0375BO | 6 | In distribution | |
| 510250 | In distribution | ||
| HD0350BL | In distribution | ||
| 600175 | 6 | In distribution | |
| SH0750BL | In distribution | ||
| HD1150BO | 6 | In distribution | |
| 510950 | In distribution | ||
| HD0500BL | In distribution | ||
| SH0575BL | In distribution | ||
| 500500 | In distribution | ||
| HD1250BL | In distribution | ||
| HD0700BL | In distribution | ||
| SH0050BO | 6 | In distribution | |
| HD1500BL | In distribution | ||
| 410450 | In distribution | ||
| SH0350BL | In distribution | ||
| SH0300BO | 6 | In distribution | |
| HD0800BO | 6 | In distribution | |
| 710125 | 30 | In distribution | |
| SH0375BO | 6 | In distribution | |
| HD0075BO | 6 | In distribution | |
| 711050 | 30 | In distribution | |
| SH0125BL | In distribution | ||
| SH0175BL | In distribution | ||
| 410300 | In distribution | ||
| HD0400BO | 6 | In distribution | |
| SH1400BO | 6 | In distribution | |
| SH1450BO | 6 | In distribution | |
| 610500 | 6 | In distribution | |
| SH0750BO | 6 | In distribution | |
| 610525 | 6 | In distribution | |
| 510425 | In distribution | ||
| SH0100BO | 6 | In distribution | |
| 510150 | In distribution | ||
| SH0250BO | 6 | In distribution | |
| HD0300BO | 6 | In distribution | |
| SH1125BL | In distribution | ||
| HD1050BL | In distribution | ||
| 700075 | 30 | In distribution | |
| 400400 | In distribution | ||
| 411150 | In distribution | ||
| 710475 | 30 | In distribution | |
| 710300 | 30 | In distribution | |
| 510400 | In distribution | ||
| 711150 | 30 | In distribution | |
| 610300 | 6 | In distribution | |
| SH0050BL | In distribution | ||
| 710350 | 30 | In distribution | |
| 400250 | In distribution | ||
| SH0475BL | In distribution | ||
| SH0175BO | 6 | In distribution | |
| 510800 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Miru 1day Menicon Flat Pack TC CP30 | Menicon Co., Ltd. | 693 |
| Miru 1day Menicon Flat Pack TC CP90 | Menicon Co., Ltd. | 693 |
| 1-Day Flat Pack TC CP90 | Menicon Co., Ltd. | 693 |
| Miru 1day Menicon Flat Pack TC Trial6 | Menicon Co., Ltd. | 693 |
| coleyes,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 480 |
| COCOMUSE,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 444 |
| mislens,HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 288 |
| Loox | Camden Passage | 199 |
| ArtMost SoftOK Daily Wear Soft Contact Lens | Seinoh Optical Co., Ltd. | 192 |
| Myeyebb, HPM38 (polymacon) Daily Wear Soft (hydrophilic) Contact Lens | Hunan Haipuming Technology Co., Ltd. | 145 |
| Comfort Colors | NEW York Optical Intl., Inc. | 144 |
| Sophisticated Kristin Monthly | DK Medivision Co., Ltd. | 106 |
Showing 12 of 119. All products under Lenses, Soft Contact, Daily Wear
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| N17752 | 1994-11-09 | HYDROCURVE | Ciba Vision Gmbh |
| P890049 | 1994-07-06 | FINISHED METHAFILCON A CONTACT LENSES | Lombart Lenses, Ltd. |
| P910029 | 1993-11-23 | \YDRON(R) (POLYMACON) HYDROPHILIC CONTACT LENSES | Les Laboratories Blonchard |
| P880049 | 1992-07-23 | EPCON SOFT (POLYMACON) SPHERICAL AND TORIC LENSES | Epcon Laboratories |
| P830006 | 1992-04-15 | SOFTACT II (POLYMACON) | Premier Contact Lens |
| P880102 | 1992-03-05 | LOMBART (POLYMACON) SOFT CONTACT LENSES | Lombart Lenses, Ltd. |
| P880101 | 1991-12-03 | AQUAFLEX[TETRAFILCON A] CONTACT LENSES/SHELF LIFE | Unilens Corp., USA |
| P900058 | 1991-08-29 | FLEXLENS (HEFILCON A) SOFT CONTACT LENSES | Westcon Contact Lens Co., Inc. |
| P900065 | 1991-08-29 | TECHNICON-38 (POLYMACON) HYDROPHYLIC LENSES | Westcon Contact Lens Co., Inc. |
| P850002 | 1991-06-12 | ALGES(TM) (HEFILCON A) CONTACT LENS | Unilens Corp., USA |
| P840006 | 1991-04-24 | SYNSOFT(TM) (POLYMACON) BIFOCAL CONTACT LENS | Salvatori Ophthalmics Mfg. Corp. |
| P890031 | 1991-03-06 | OTI-05 & LATHE-40 (POLYMACON) LATHE-CUT HYDROPHILI | Ocular Technologies, Inc. |
| P860040 | 1990-11-21 | SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES | Wavetouch Technologies, LLC |
| P850039 | 1990-09-11 | B&L 58(TM) (ETAFILCONA) CONTACT LENS | Bausch & Lomb Incorporated |
| P890053 | 1990-09-11 | O.P.R. -55 SOFT CONTACT LENS | N & N Contact Lens Co., Ltd. |
| P890029 | 1990-03-06 | EXCELENS (ATLAFILCON A) CONTACT LENS | Ciba Vision Gmbh |
| P810005 | 1990-01-31 | WEICON (R) (TEFILICON) HYDROPHILIC CONTACT LENS | Ciba Vision Care |
| P870019 | 1989-12-11 | ADYPI (ETAFILCON A) HYDROPHILIC CONTACT LENS | Hanita Contact Lens Laboratory |
| P820059 | 1989-09-18 | PERMATINT(R) | Wesley Jessen Corp. |
| P850079 | 1989-09-06 | HYDRASOFT (METHAFILCON A) CONTACT LENS | CooperVision, Inc. |
| P870079 | 1989-06-02 | TRESOFT OCUFILCON SOFT HYDROPHILIC CONTACT LENS | United Contact Lens Inc |
| P860009 | 1989-05-09 | IGEL 67 CONTACT LENS | Contamac Ltd. |
| P800031 | 1989-05-05 | (MAFILCON) SOFT CONTACT LENSES | N&N Menicon, Inc. |
| P850078 | 1989-03-14 | KONTUR SOFT (METHAFILCON A) LENS | Kontur Kontact Lens Co., Inc. |
| P830077 | 1989-02-21 | METRO 55 (METHAFILCON A) | Metrosoft, Inc. |
| N17554 | 1989-01-12 | SOFTCON (VIFILCON A) SOFT CONTACT CORRECTIVE LENS | Ciba Vision Care |
| P820026 | 1988-11-10 | METROSOFT(TM) II (POLYMACON) HYDROPHILIC CONTACT | Metrosoft, Inc. |
| P820051 | 1988-09-19 | STERILIZED FINISHED OCUFILCON B LENSES | Ocu-Ease Optical Products, Inc. |
| P830012 | 1988-08-29 | SOFTICS(TM) (POLYMACON) | Ideal Optics, Inc. |
| P840071 | 1987-10-27 | TINTED TETRAFILCON A CONTACT LENSES | Ciba Vision Gmbh |
| P830003 | 1987-09-28 | SOFTVIEW SPHERICAL & TORIC CONTACT LENS | Optical Plastic Research |
| N17987 | 1987-06-16 | SOFT CONTACT LENS | Ciba Vision Gmbh |
| P820005 | 1987-02-20 | (POLYMACON) CONTACT LENSES | Salvatori Ophthalmics Mfg. Corp. |
| P800020 | 1985-11-05 | SILSOFT (ELASTOFILCON A ) CONTACT LENS | Dow Corning Corp. Healthcare Industries Materials |
| N17793 | 1985-09-30 | SOFTSITE (HEFILCON A) CONTACT LENS | Unilens Corp., USA |
| N17734 | 1985-08-15 | ACCUSEPT DISINFECTING UNIT | Strieter Laboratories, Inc. |
| N17375 | 1985-07-22 | SOFTCON BANDAGE LENS | Ciba Vision Care |
| N17976 | 1984-12-10 | FLEXLENS | Paragon Vision Sciences, Inc. |
| P810050 | 1984-11-20 | OPTECH FRE-FLEX SOFT CONTACT LENS | Optech, Inc. |
| N17855 | 1984-03-29 | TRESOFT SOFT CONTACT LENSE | Ciba Vision Care |
| P800054 | 1984-03-12 | SILCON(R) (SILAFILCON A) CONTACT LENS DAILY WEAR | Dow Corning Corp. Healthcare Industries Materials |
| P820078 | 1984-01-30 | AL-47 SOFT CONTACT LENS | Alden Optical Labs., Inc. |
| P820017 | 1983-04-28 | HYDRACON(R) CONTACT LENSES | Hydracon |
| P800011 | 1982-11-23 | WEICON (TEFILCON) HYDROPHILIC CONTACT LENSES | Ciba Vision Gmbh |
| P810057 | 1982-10-08 | COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS | CooperVision, Inc. |
| P800070 | 1982-03-01 | SOFTACT(TM) (DELTAFILCON A) | Premier Contact Lens |
| P800013 | 1982-02-05 | METROSOFT(DELTAFILCONA) HYDROPHILIC CONTACT LENSES | Metrosoft, Inc. |
| N18146 | 1981-11-27 | SOF FORM (DELTAFILCON A) | Unilens Corp., USA |
| N18180 | 1981-05-11 | CUSTOMFLEX (DELTAFILCON A) HYDROPHILIC CONTACT LEN | Wesley Jessen Corp. |
| N17852 | 1980-10-17 | DURASOFT CONTACT LENS | Wesley Jessen Corp. |
| P780013 | 1980-06-19 | TRI POL 43 CONTACT LENS | Gbf Contact Lenses, Inc. |
| N18018 | 1980-05-21 | ARMSOF SOFT CONTACT LENSE | Lombart Optical of Virginia, Ltd. |
| P790015 | 1980-04-25 | SOFTICS (DELTAFILCON A) LENS | Advanced Soft Optics, Inc. |
| N17722 | 1980-03-14 | GELFLEX(R) (DIMEFILCON A) CONTACT LENS | Dow Corning Ophthalmics, Inc. |
| N18001 | 1979-08-08 | MINITHEERM | Ciba Vision Care |
| N18162 | 1979-06-07 | TRI POL | Aquarius Soft Lens, Inc. |
| N17951 | 1979-03-23 | TRI POL 43 CONTACT LENS | Applied Optics, Inc. |
| N17676 | 1979-02-26 | NATUREVUE CONTACT LENSE | Bausch & Lomb Incorporated |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.