The following data is part of a premarket notification filed by Dental Photonics, Inc with the FDA for Stlase.
Device ID | K111689 |
510k Number | K111689 |
Device Name: | STLASE |
Classification | Powered Laser Surgical Instrument |
Applicant | DENTAL PHOTONICS, INC 131 Kelekent Lane Cary, NC 27518 |
Contact | Marcy Moore |
Correspondent | Marcy Moore DENTAL PHOTONICS, INC 131 Kelekent Lane Cary, NC 27518 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-06-16 |
Decision Date | 2012-02-16 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
STLASE 77825585 not registered Dead/Abandoned |
Dental Photonics, Inc. 2009-09-14 |
STLASE 75772481 not registered Dead/Abandoned |
S.L.T. Japan Co., Ltd. 1999-08-11 |