510(k) K122950
K122950 is an FDA 510(k) premarket notification submitted by Theradome, Inc. for the device "LASER HELMET". The FDA issued a decision of Substantially Equivalent on Jun 14, 2013. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Theradome, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 14, 2013
- Date Received
- Sep 25, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Laser, Comb, Hair
- Device Class
- Class II
- Regulation Number
- 890.5500
- Review Panel
- SU
- Submission Type
- 510(k)
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