MediWorks
AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the…
AC-powered slit lamp biomicroscopes intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. They are used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.
Who Else Makes It
Concentrated in Jiangsu (3), Chongqing (2), Beijing (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Chongqing Kanghua Ruiming S&T Co., Ltd. | Chongqing | Chongqing | Contract manufacturer | 3 |
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Taizhou City K&W International Trade Co., Ltd. | Jiangyan | Jiangsu | Repacker / relabeller | 38 |
| Lianyungang Tiannuo Optical Instrument Co., Ltd. | Lianyungang | Jiangsu | Contract manufacturer | 31 |
| 66 Vision Tech Co., Ltd. | Suzhou | Jiangsu | Private-label distributor | 24 |
| Shanghai Mediworks Precision Instruments Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 13 |
| Chongqing Sunkingdom Medical Instrument Co., Ltd. | Chongqing | Chongqing | Manufacturer | 11 |
Record
| Listed by | Shanghai Mediworks Precision Instruments Co., Ltd., China |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Contract manufacturer, Manufacturer |
| 510(k) | K152429 |
| Record published | 2016-08-01 |
| Record revised | 2022-12-20 (version 8) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| S390H | In distribution | |
| SL350H | In distribution | |
| S350C | In distribution | |
| SL450L | In distribution | |
| S390L | In distribution | |
| SL400L | In distribution | |
| S260S | In distribution | |
| FC160 | In distribution | |
| S350 | In distribution | |
| SL400H | In distribution | |
| S260 | In distribution | |
| SL350L | In distribution | |
| RSL 2100 | In distribution | |
| SL300H | In distribution | |
| S280C | In distribution | |
| SL650 | In distribution | |
| S290 | In distribution | |
| SL450H | In distribution | |
| TSL-900H | In distribution | |
| S360 | In distribution | |
| S280 | In distribution | |
| S350S | In distribution | |
| S280S | In distribution | |
| RSL 2600digital | In distribution | |
| SL650+ | In distribution | |
| SL300L | In distribution | |
| RSL 2600 | In distribution | |
| TSL-900Z | In distribution | |
| S360S | In distribution | |
| TSL-900Hdigital | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| Marco | Takagi Seiko Co., Ltd. | 17 |
| Gilras | U.S. Ophthalmic, L.L.C. | 16 |
| Visionix | Luneau Technology Operations | 15 |
| LED Slit Lamp | Right MFG. Co., Ltd. | 13 |
| Tiannuo / Tnmed | Lianyungang Tiannuo Optical Instrument Co., Ltd. | 12 |
| Eli Ezer | U.S. Ophthalmic, L.L.C. | 12 |
| Inami | Inami & Co., Ltd. | 11 |
| Zoom Slit Lamp | Right MFG. Co., Ltd. | 8 |
| Slit Lamp BQ 900 | Haag-Streit AG | 8 |
| PolyLock Small Bone | Fusion Orthopedics, LLC | 7 |
| Kowa SL-19 | Kowa Co., Ltd. | 7 |
Showing 12 of 168. All products under Biomicroscope, Slit-Lamp, Ac-Powered
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K152429 | 2016-05-11 |
| K100439 | 2010-07-16 |
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.