The following data is part of a premarket notification filed by Dermacare, Inc. with the FDA for Thermaclear.
Device ID | K060653 |
510k Number | K060653 |
Device Name: | THERMACLEAR |
Classification | Powered Laser Surgical Instrument |
Applicant | DERMACARE, INC. 6248 PRESTON AVENUE Livermore, CA 94551 |
Contact | Heidi Stark |
Correspondent | Heidi Stark DERMACARE, INC. 6248 PRESTON AVENUE Livermore, CA 94551 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-03-13 |
Decision Date | 2006-10-24 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
THERMACLEAR 97503819 not registered Live/Pending |
Stryker Corporation 2022-07-14 |
THERMACLEAR 97254056 not registered Live/Pending |
ECM Technologies LLC 2022-02-04 |
THERMACLEAR 78703318 3363316 Dead/Cancelled |
Therative, Inc. 2005-08-30 |
THERMACLEAR 73580690 1420998 Dead/Cancelled |
JOHNSON & JOHNSON 1986-01-31 |