The following data is part of a premarket notification filed by Laser Peripherals, Llc. with the FDA for Laser Peripherals Reusable Holmium Fiber.
| Device ID | K011207 |
| 510k Number | K011207 |
| Device Name: | LASER PERIPHERALS REUSABLE HOLMIUM FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PERIPHERALS, LLC. 1000 BOONE AVE NORTH SUITE 300 Golden Valley, MN 55427 |
| Contact | Nancy Arnold |
| Correspondent | Nancy Arnold LASER PERIPHERALS, LLC. 1000 BOONE AVE NORTH SUITE 300 Golden Valley, MN 55427 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-19 |
| Decision Date | 2001-07-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816469020899 | K011207 | 000 |
| 00816469020745 | K011207 | 000 |
| 00816469020738 | K011207 | 000 |
| 00816469020721 | K011207 | 000 |
| 00816469020714 | K011207 | 000 |
| 00816469020707 | K011207 | 000 |
| 00816469020691 | K011207 | 000 |
| 00816469020684 | K011207 | 000 |
| 00816469020677 | K011207 | 000 |
| 00816469020660 | K011207 | 000 |
| 00816469020653 | K011207 | 000 |
| 00816469020646 | K011207 | 000 |
| 00816469021575 | K011207 | 000 |
| 00816469020752 | K011207 | 000 |
| 00816469020769 | K011207 | 000 |
| 00816469020882 | K011207 | 000 |
| 00816469020875 | K011207 | 000 |
| 00816469020868 | K011207 | 000 |
| 00816469020851 | K011207 | 000 |
| 00816469020844 | K011207 | 000 |
| 00816469020837 | K011207 | 000 |
| 00816469020820 | K011207 | 000 |
| 00816469020813 | K011207 | 000 |
| 00816469020806 | K011207 | 000 |
| 00816469020790 | K011207 | 000 |
| 00816469020783 | K011207 | 000 |
| 00816469020776 | K011207 | 000 |
| 00816469021568 | K011207 | 000 |