The following data is part of a premarket notification filed by Aesculap-meditec North America with the FDA for Dermablate Er: Yag Laser System.
| Device ID | K980361 |
| 510k Number | K980361 |
| Device Name: | DERMABLATE ER: YAG LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Contact | William T Kelley |
| Correspondent | William T Kelley AESCULAP-MEDITEC NORTH AMERICA 23832 VIA MONTE Coto De Caza, CA 92679 -4001 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-29 |
| Decision Date | 1998-04-21 |
| Summary: | summary |