The following data is part of a premarket notification filed by Strata Skin Sciences, Inc. with the FDA for Mmd Tip.
| Device ID | K181480 |
| 510k Number | K181480 |
| Device Name: | MMD Tip |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Strata Skin Sciences, Inc. 100 Lakeside Dr. Suite 100 Horsham, PA 19044 |
| Contact | Shmuel Gov |
| Correspondent | Paul Dryden Strata Skin Sciences, Inc. % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, FL 33704 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-05 |
| Decision Date | 2018-08-01 |
| Summary: | summary |