Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- Subpart D—Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- NZYLight, Lymphedema Reduction, Low Energy2Product Code
- OAPLaser, Comb, Hair2Product Code
- K231321Nooance Led And Laser Helmet2Cleared 510(K)
- K231153Neuhat Hair Growth System; ibeauty.com Laser Cap2Cleared 510(K)
- K222790F65 Laser System2Cleared 510(K)
- K230134Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-0022Cleared 510(K)
- K230597Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)2Cleared 510(K)
- K223862Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp2Cleared 510(K)
- K230336CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)2Cleared 510(K)
- K222477Hair Growth Device2Cleared 510(K)
- K222364Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)2Cleared 510(K)
- K222081ID-510 iRestore Elite2Cleared 510(K)
- Show All 89 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
ID-510 iRestore Elite
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K222081
- 510(k) Type
- Traditional
- Applicant
- Freedom Laser Therapy, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 10/13/2022
- Days to Decision
- 90 days
- Submission Type
- Summary