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 |