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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
- K250308Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)2Cleared 510(K)
- 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)
Show All 101 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K250308
- 510(k) Type
- Traditional
- Applicant
- Dongguan Boyuan Intelligent Technology Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 4/29/2025
- Days to Decision
- 85 days
- Submission Type
- Summary