The following data is part of a premarket notification filed by Laser Aesthetics, Inc. with the FDA for Cooltouch V Nd:yag.
| Device ID | K983984 |
| 510k Number | K983984 |
| Device Name: | COOLTOUCH V ND:YAG |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER AESTHETICS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Contact | Jonathan M Baumgardner |
| Correspondent | Jonathan M Baumgardner LASER AESTHETICS, INC. 11802 KEMPER RD. Auburn, CA 95603 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-09 |
| Decision Date | 1999-06-07 |
| Summary: | summary |