The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Thermalite Diode Laser Series, Diode 980, 810, 940.
Device ID | K952661 |
510k Number | K952661 |
Device Name: | SLT THERMALITE DIODE LASER SERIES, DIODE 980, 810, 940 |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
Contact | Richard G Jones |
Correspondent | Richard G Jones SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-12 |
Decision Date | 1995-10-06 |