Anesthesiology
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- 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
- K240456Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap2Cleared 510(K)
- K240064Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom2Cleared 510(K)
- K232356Laser Cap, Model: Hat-012Cleared 510(K)
- 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)
- Show All 92 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
F65 Laser System
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K222790
- 510(k) Type
- Traditional
- Applicant
- Lumenis Be, Ltd.
- Country
- Israel
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/14/2023
- Days to Decision
- 272 days
- Submission Type
- Summary