The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for Lpi Ml210 Holmium Surgical Laser, Modification.
| Device ID | K914827 |
| 510k Number | K914827 |
| Device Name: | LPI ML210 HOLMIUM SURGICAL LASER, MODIFICATION |
| 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 | 1991-10-22 |
| Decision Date | 1992-03-27 |