510(k) K181253
K181253 is an FDA 510(k) premarket notification submitted by Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC for the device "Bosley Revitalizer 272 Laser Cap, Bosley Revitalizer 164 Laser Cup". The FDA issued a decision of Substantially Equivalent on Aug 10, 2018. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 10, 2018
- Date Received
- May 11, 2018
- 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)
Promote hair growth in males with androgenic alopecia and norwood hamilton classification of iia to v