510(k) K192585
K192585 is an FDA 510(k) premarket notification submitted by Pjm Worldwide, LLC D/B/A Phoenix Medical Technology, LLC for the device "Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap". The FDA issued a decision of Substantially Equivalent on Jan 29, 2020. 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
- Jan 29, 2020
- Date Received
- Sep 19, 2019
- 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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