510(k) K161875
K161875 is an FDA 510(k) premarket notification submitted by Transdermal Cap, Inc. for the device "LaserCap300, LaserCap224, LaserCap120, LaserCap80". The FDA issued a decision of Substantially Equivalent on Sep 30, 2016. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Transdermal Cap, Inc. has 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 30, 2016
- Date Received
- Jul 8, 2016
- 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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