The following data is part of a premarket notification filed by Aesculight, Llc with the FDA for Aesculight Family Of Flexible Fibers, Handpieces And Tips For Co2 Surgical Lasers.
| Device ID | K081612 |
| 510k Number | K081612 |
| Device Name: | AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AESCULIGHT, LLC 16928 WOOD-RED ROAD N.E. SUITE B104 Woodinville, WA 98072 |
| Contact | Paul Diaz |
| Correspondent | Paul Diaz AESCULIGHT, LLC 16928 WOOD-RED ROAD N.E. SUITE B104 Woodinville, WA 98072 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-06-09 |
| Decision Date | 2008-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851842007425 | K081612 | 000 |
| 00851842007562 | K081612 | 000 |
| 00851842007579 | K081612 | 000 |
| 00851842007289 | K081612 | 000 |
| 00851842007296 | K081612 | 000 |
| 00851842007012 | K081612 | 000 |
| 00851842007210 | K081612 | 000 |
| 00851842007234 | K081612 | 000 |
| 00851842007258 | K081612 | 000 |
| 00851842007272 | K081612 | 000 |
| 10851842007289 | K081612 | 000 |
| 10851842007296 | K081612 | 000 |
| 00851842007357 | K081612 | 000 |
| 00851842007388 | K081612 | 000 |
| 00851842007395 | K081612 | 000 |
| 00851842007401 | K081612 | 000 |
| 00851842007418 | K081612 | 000 |
| 00851842007661 | K081612 | 000 |