ID-510 iRestore Elite— 510(k) K222081
Substantially EquivalentFreedom Laser Therapy, Inc.
FDA 510(k) clearance K222081 for ID-510 iRestore Elite, Substantially Equivalent on 2022-10-13. Applicant: Freedom Laser Therapy, Inc.. Device class: 2.
Clearance details
- Applicant
- Freedom Laser Therapy, Inc.
- Product code
- Code OAP
- Device class
- Class 2
- Regulation
- 21 CFR 890.5500
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
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