The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for Lpi Ml 100/532 And Ml 532 Surgical Laser.
Device ID | K915631 |
510k Number | K915631 |
Device Name: | LPI ML 100/532 AND ML 532 SURGICAL LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | LASER PHOTONICS, INC. 12351 RESEARCH PKWY. Orlando, FL 32826 |
Contact | Robert Anselmo |
Correspondent | Robert 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 | 1991-12-17 |
Decision Date | 1992-06-15 |