The following data is part of a premarket notification filed by Laser Photonics, Inc. with the FDA for L.p.i. Laser Delivery System.
Device ID | K904331 |
510k Number | K904331 |
Device Name: | L.P.I. LASER DELIVERY SYSTEM |
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 | 1990-09-21 |
Decision Date | 1990-12-17 |