The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for Laser Photonics Ml-210 Holmium:yag Medi Lase Syst.
| Device ID | K910233 |
| 510k Number | K910233 |
| Device Name: | LASER PHOTONICS ML-210 HOLMIUM:YAG MEDI LASE SYST |
| Classification | Powered Laser Surgical Instrument |
| Applicant | LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
| Contact | Robert J Anselmo |
| Correspondent | Robert J Anselmo 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 | 1991-01-18 |
| Decision Date | 1991-04-12 |