The following data is part of a premarket notification filed by Ophthalmed Llc with the FDA for 20g Sma Laser Fiber, Model Lf20; 25g Sma Laser Fiber, Model Lf25.
| Device ID | K021696 |
| 510k Number | K021696 |
| Device Name: | 20G SMA LASER FIBER, MODEL LF20; 25G SMA LASER FIBER, MODEL LF25 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | OPHTHALMED LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour OPHTHALMED LLC 1308 MORNINGSIDE PARK DR. Alpharetta, GA 30022 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-22 |
| Decision Date | 2002-08-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B384VS013025I5 | K021696 | 000 |
| B384VS011023A5 | K021696 | 000 |
| B384VS011025A5 | K021696 | 000 |
| B384VS012020A5 | K021696 | 000 |
| B384VS012025A5 | K021696 | 000 |
| B384VS012027A5 | K021696 | 000 |
| B384012027I5 | K021696 | 000 |
| B384VS013020A5 | K021696 | 000 |
| B384VS013023A5 | K021696 | 000 |
| B384VS013023I5 | K021696 | 000 |
| B384VS013025A5 | K021696 | 000 |
| B384VS011020A5 | K021696 | 000 |