Marco
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to…
An AC-powered slit-lamp biomicroscope and accessories intended for use in the examination of the anterior eye segment, from the cornea epithelium to the posterior capusule. It is used to aid in the diagnosis of diseases or traumas which affect 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 | Takagi Seiko Co., Ltd., Japan |
|---|---|
| FDA product code | HJO |
| Device type | Biomicroscope, Slit-Lamp, Ac-Powered |
| Device class | Class 2 |
| Regulation | 21 CFR 886.1850 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K930438 |
| Record published | 2016-08-26 |
| Record revised | 2022-12-20 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 10 to 35 °C; Handling environment humidity 30 to 90 % RH; Handling environment atmospheric pressure 80 to 106 KiloPascal |
| Distribution end date | 2018-10-24 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| MARCO ULTRA M2 | In distribution | |
| MARCO ULTRA M3 | In distribution | |
| MARCO ULTRA M5 | In distribution | |
| MARCO ULTRA M4 | In distribution | |
| MARCO ULTRA M2 BI | In distribution | |
| MARCO 5 ULTRA SLITLAMP | Withdrawn | |
| MARCO ULTRA M4 | Withdrawn | |
| MARCO ULTRA M2 | Withdrawn | |
| MARCO ULTRA MAX2 | Withdrawn | |
| MARCO ULTRA M5 | Withdrawn | |
| MARCO ULTRAM3 | Withdrawn | |
| MARCO G5 ULTRA SLITLAMP | Withdrawn | |
| MARCO G2 ULTRA SLITLAMP | Withdrawn | |
| MARCO 2B ULTRA SLITLAMP | Withdrawn | |
| MARCO ULTRA MAX5 | Withdrawn | |
| MARCO G4 ULTRA SLITLAMP | Withdrawn | |
| MARCO ULTRA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MediWorks | Shanghai Mediworks Precision Instruments Co., Ltd. | 30 |
| S4 Optik | Costruzioni Strumenti Oftalmici C.S.O. SRL | 24 |
| 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 |
|---|---|
| K162636 | 2017-04-14 |
| K152535 | 2016-05-26 |
| K063352 | 2007-03-13 |
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.