The following data is part of a premarket notification filed by Strata Skin Sciences, Inc. with the FDA for Xtrac Momentum Excimer Laser System.
| Device ID | K193478 |
| 510k Number | K193478 |
| Device Name: | XTRAC Momentum Excimer Laser System |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Strata Skin Sciences, Inc. 5 Walnut Grove Drive, Suite 140 Horsham, PA 19044 |
| Contact | Chuck Mierkiewicz |
| Correspondent | Paul Dryden Strata Skin Sciences, Inc. C/o ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-01-14 |