The following data is part of a premarket notification filed by Laser Peripherals Llc. with the FDA for Bare Laser Fiber Models Dblf-40, Dblf-60, Dblf-60-1, Dclf-600b, Dslf-60, Dblf-100.
| Device ID | K030959 |
| 510k Number | K030959 |
| Device Name: | BARE LASER FIBER MODELS DBLF-40, DBLF-60, DBLF-60-1, DCLF-600B, DSLF-60, DBLF-100 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PERIPHERALS LLC. 1000 BOONE AVENUE NORTH SUITE 300 Golden Valley, MN 55427 |
| Contact | Jeffrey M Stein |
| Correspondent | Jeffrey M Stein LASER PERIPHERALS LLC. 1000 BOONE AVENUE NORTH SUITE 300 Golden Valley, MN 55427 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-27 |
| Decision Date | 2003-04-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816469021155 | K030959 | 000 |
| 00816469020141 | K030959 | 000 |
| 00816469020134 | K030959 | 000 |
| 00816469020127 | K030959 | 000 |
| 00816469020110 | K030959 | 000 |
| 00816469020103 | K030959 | 000 |
| 00816469020097 | K030959 | 000 |
| 00816469020080 | K030959 | 000 |
| 00816469020073 | K030959 | 000 |
| 00816469020066 | K030959 | 000 |
| 00816469020059 | K030959 | 000 |
| 00816469020042 | K030959 | 000 |
| 00816469020035 | K030959 | 000 |
| 00816469020028 | K030959 | 000 |
| 00816469020011 | K030959 | 000 |
| 00816469020158 | K030959 | 000 |
| 00816469020165 | K030959 | 000 |
| 00816469020172 | K030959 | 000 |
| 00816469020318 | K030959 | 000 |
| 00816469020301 | K030959 | 000 |
| 00816469020295 | K030959 | 000 |
| 00816469020288 | K030959 | 000 |
| 00816469020271 | K030959 | 000 |
| 00816469020264 | K030959 | 000 |
| 00816469020257 | K030959 | 000 |
| 00816469020240 | K030959 | 000 |
| 00816469020233 | K030959 | 000 |
| 00816469020226 | K030959 | 000 |
| 00816469020219 | K030959 | 000 |
| 00816469020202 | K030959 | 000 |
| 00816469020196 | K030959 | 000 |
| 00816469020189 | K030959 | 000 |
| 00816469020004 | K030959 | 000 |