The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Contact Laser System.
Device ID | K882212 |
510k Number | K882212 |
Device Name: | SLT CONTACT LASER SYSTEM |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Contact | Cyndy Gifford |
Correspondent | Cyndy Gifford SURGICAL LASER TECHNOLOGIES, INC. ONE GREAT VALLEY PKWY. Malvern, PA 19355 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-05-26 |
Decision Date | 1988-08-17 |