The following data is part of a premarket notification filed by U.s. Ophthalmic Llc with the FDA for Luxvision Slit Lamp.
| Device ID | K063416 |
| 510k Number | K063416 |
| Device Name: | LUXVISION SLIT LAMP |
| Classification | Biomicroscope, Slit-lamp, Ac-powered |
| Applicant | U.S. OPHTHALMIC LLC 7255 NW 68 ST. UNIT #9 Miami, FL 33166 |
| Contact | Al Weisenborn |
| Correspondent | Al Weisenborn U.S. OPHTHALMIC LLC 7255 NW 68 ST. 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 | 2006-11-13 |
| Decision Date | 2006-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851158007355 | K063416 | 000 |
| 00851158007010 | K063416 | 000 |
| 00851158007027 | K063416 | 000 |
| 00851158007034 | K063416 | 000 |
| 00851158007041 | K063416 | 000 |
| 00851158007294 | K063416 | 000 |
| 00851158007300 | K063416 | 000 |
| 00851158007317 | K063416 | 000 |
| 00851158007324 | K063416 | 000 |
| 00851158007331 | K063416 | 000 |
| 00851158007348 | K063416 | 000 |
| 00851158007003 | K063416 | 000 |