The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Multidimensional Contact Laser Syst A4060c.
Device ID | K930490 |
510k Number | K930490 |
Device Name: | SLT MULTIDIMENSIONAL CONTACT LASER SYST A4060C |
Classification | Powered Laser Surgical Instrument |
Applicant | SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
Contact | Thomas Becze |
Correspondent | Thomas Becze 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 | 1993-01-29 |
Decision Date | 1993-03-31 |