510(k) K161046
K161046 is an FDA 510(k) premarket notification submitted by Theradome, Inc. for the device "Laser Helmet LH40-EVO". The FDA issued a decision of Substantially Equivalent on May 12, 2016. 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
- May 12, 2016
- Date Received
- Apr 13, 2016
- Clearance Type
- Special
- 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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