The following data is part of a premarket notification filed by Aesculap-meditec North America with the FDA for Mcl 29 Dermablate Er:yag Laser System.
| Device ID | K992707 |
| 510k Number | K992707 |
| Device Name: | MCL 29 DERMABLATE ER:YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AESCULAP-MEDITEC NORTH AMERICA 2525 MCGAW AVE. Irvine, CA 92623 -9791 |
| Contact | William Kelley |
| Correspondent | William Kelley AESCULAP-MEDITEC NORTH AMERICA 2525 MCGAW AVE. Irvine, CA 92623 -9791 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-11 |
| Decision Date | 1999-10-19 |
| Summary: | summary |