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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
- K253349Hair Regrowth Cap (Model: T-119-HRC)2Cleared 510(K)
- K252414Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)2Cleared 510(K)
- K252325Hair Growth Laser Cap2Cleared 510(K)
- K251017CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)2Cleared 510(K)
- K250467Red Light Hair Growth Cap (LP-RJVGRW-BLK)2Cleared 510(K)
- 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)
Show All 106 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K251017
- 510(k) Type
- Traditional
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 6/17/2025
- Days to Decision
- 76 days
- Submission Type
- Summary