The following data is part of a premarket notification filed by Theravant Corporation with the FDA for Theraclear.
Device ID | K101415 |
510k Number | K101415 |
Device Name: | THERACLEAR |
Classification | Powered Laser Surgical Instrument |
Applicant | THERAVANT CORPORATION 131 Kelekent Lane Cary, NC 27518 |
Contact | Marcy Moore |
Correspondent | Marcy Moore THERAVANT CORPORATION 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 | 2010-05-20 |
Decision Date | 2010-07-08 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERACLEAR 85142527 4088773 Live/Registered |
Theravant Corporation 2010-09-30 |
THERACLEAR 75468121 2240798 Live/Registered |
Aromaland, Inc. 1998-04-15 |