The following data is part of a premarket notification filed by Laser Peripherals, Llc with the FDA for Laser Peripherals, Llc Family Of Bare Laser Fibers.
| Device ID | K170366 |
| 510k Number | K170366 |
| Device Name: | Laser Peripherals, LLC Family Of Bare Laser Fibers |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Laser Peripherals, LLC 13355 10th Ave, Suite 110 Plymouth, MN 55441 |
| Contact | Jeff Stein |
| Correspondent | Jeff Stein Laser Peripherals, LLC 13355 10th Ave, Suite 110 Plymouth, MN 55441 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-06 |
| Decision Date | 2017-06-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816469021230 | K170366 | 000 |
| 00816469021636 | K170366 | 000 |
| 00816469021599 | K170366 | 000 |
| 00816469021605 | K170366 | 000 |
| 00816469021582 | K170366 | 000 |
| 00816469021537 | K170366 | 000 |
| 00816469021544 | K170366 | 000 |
| 00816469021551 | K170366 | 000 |
| 00816469021520 | K170366 | 000 |
| 00816469021179 | K170366 | 000 |
| 00816469021186 | K170366 | 000 |
| 00816469021193 | K170366 | 000 |
| 00816469021209 | K170366 | 000 |
| 00816469021216 | K170366 | 000 |
| 00816469021223 | K170366 | 000 |
| 00816469021629 | K170366 | 000 |