The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for Laser Photonics Ml755 Dermablaser.
| Device ID | K934501 |
| 510k Number | K934501 |
| Device Name: | LASER PHOTONICS ML755 DERMABLASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Clement C Darrow |
| Correspondent | Clement C Darrow LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-14 |
| Decision Date | 1994-08-30 |