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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
- K242747FAQ™ (302)2Cleared 510(K)
- K242619GroWell BT Hair Growth System (GW10042)2Cleared 510(K)
- K242363HIGHERDOSE Red Light Hat (HG-120K)2Cleared 510(K)
- K241342Hair Growth Comb (SZ-23,SZ-23A)2Cleared 510(K)
- K242620Breo Laser Hair Growth Comb (Scalp 3L)2Cleared 510(K)
- K240472PBM Hair Therapy Cap2Cleared 510(K)
- K240689Robin's Egg2Cleared 510(K)
- K242441Revian Lyte (10011)2Cleared 510(K)
- 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)
Show All 100 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K240456
- 510(k) Type
- Special
- Applicant
- PLM Worldwide, LLC d/b/a Phoenix Medical Technology, LLC
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/22/2024
- Days to Decision
- 97 days
- Submission Type
- Summary