The following data is part of a premarket notification filed by Usophthalmic, Llc with the FDA for Gilras Slit Lamp, Models Gr-sl7, Gr-sl36, Gr-sl54 And Gr-sl72.
| Device ID | K080776 |
| 510k Number | K080776 |
| Device Name: | GILRAS SLIT LAMP, MODELS GR-SL7, GR-SL36, GR-SL54 AND GR-SL72 |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | USOPHTHALMIC, LLC 7255 NW 88TH STREET UNIT 9 Miami, FL 33166 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn USOPHTHALMIC, LLC 7255 NW 88TH STREET UNIT 9 Miami, FL 33166 |
| Product Code | HJO |
| CFR Regulation Number | 886.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-09-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851158007270 | K080776 | 000 |
| 00851158007133 | K080776 | 000 |
| 00851158007140 | K080776 | 000 |
| 00851158007157 | K080776 | 000 |
| 00851158007164 | K080776 | 000 |
| 00851158007171 | K080776 | 000 |
| 00851158007188 | K080776 | 000 |
| 00851158007195 | K080776 | 000 |
| 00851158007201 | K080776 | 000 |
| 00851158007218 | K080776 | 000 |
| 00851158007225 | K080776 | 000 |
| 00851158007232 | K080776 | 000 |
| 00851158007249 | K080776 | 000 |
| 00851158007256 | K080776 | 000 |
| 00851158007263 | K080776 | 000 |
| 00851158007126 | K080776 | 000 |