The following data is part of a premarket notification filed by Theravant Corporation with the FDA for Acleara, Theraclear.
| Device ID | K123889 |
| 510k Number | K123889 |
| Device Name: | ACLEARA, THERACLEAR |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| 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 | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-12-18 |
| Decision Date | 2013-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B305THERACLEAR10 | K123889 | 000 |