510(k) K222081
K222081 is an FDA 510(k) premarket notification submitted by Freedom Laser Therapy, Inc. for the device "ID-510 iRestore Elite". The FDA issued a decision of Substantially Equivalent on Oct 13, 2022. The device falls under product code OAP (Laser, Comb, Hair), a Class II device regulated under 21 CFR 890.5500. Freedom Laser Therapy, Inc. has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 13, 2022
- Date Received
- Jul 15, 2022
- 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