510(k) K132646
K132646 is an FDA 510(k) premarket notification submitted by Sunetics International Marketing Group, LLC for the device "SUNETICS CLINICAL BIO-STIMULATION LASER". The FDA issued a decision of Substantially Equivalent on Dec 20, 2013. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Sunetics International Marketing Group, LLC has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 20, 2013
- Date Received
- Aug 26, 2013
- 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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