The following data is part of a premarket notification filed by Sentient Manufacturing Llc with the FDA for Sentient Manufacturing Laser Fiber.
| Device ID | K213554 |
| 510k Number | K213554 |
| Device Name: | Sentient Manufacturing Laser Fiber |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Sentient Manufacturing LLC 4384 N Forestdale Dr., Suite 202 Park City, UT 84098 |
| Contact | Jim Mousseau |
| Correspondent | Kevin Morningstar Morningstar Consulting Group LLC 20319 E Costilla Ave Centennial, CO 80016 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-08 |
| Decision Date | 2022-02-02 |