LASER HELMET
Laser, Comb, Hair
THERADOME INC.
The following data is part of a premarket notification filed by Theradome Inc. with the FDA for Laser Helmet.
Pre-market Notification Details
| Device ID | K122950 |
| 510k Number | K122950 |
| Device Name: | LASER HELMET |
| Classification | Laser, Comb, Hair |
| Applicant | THERADOME INC. 4900 HOPYARD ROAD SUITE 100 Pleasanton, CA 94588 |
| Contact | Larry Petersen |
| Correspondent | Larry Petersen THERADOME INC. 4900 HOPYARD ROAD SUITE 100 Pleasanton, CA 94588 |
| Product Code | OAP |
| CFR Regulation Number | 890.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-25 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B399PRO0800 | K122950 | 000 |
Trademark Results [LASER HELMET]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 LASER HELMET 85271613 not registered Dead/Abandoned |
Theradome, Inc. 2011-03-20 |
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