THERACLEAR
Powered Laser Surgical Instrument
THERAVANT CORPORATION
The following data is part of a premarket notification filed by Theravant Corporation with the FDA for Theraclear.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M709THCLR01 | K101415 | 000 |
Trademark Results [THERACLEAR]
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 |
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