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
- Diagnostic DevicesCFR Sub-Part
- General Hospital and Personal Use Monitoring DevicesCFR Sub-Part
- General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- MiscellaneousMiscellaneous
- Neurological Surgical DevicesCFR Sub-Part
- Physical Medicine Therapeutic DevicesCFR Sub-Part
- NZYLight, Lymphedema Reduction, Low Energy2Product Code
- OAPLaser, Comb, Hair2Product Code
- K213027Laser Hair Growth Comb2Cleared 510(K)
- K213025Laser hair growth helmet2Cleared 510(K)
- K220543Auxo A300, A150 and APod2Cleared 510(K)
- K213447LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.2Cleared 510(K)
- K213094ID-500 iRestore Hair Growth System2Cleared 510(K)
- K211192Grivamax Family of Lasers, Models 272 and 1482Cleared 510(K)
- K211038Biophotas Celluma RESTORE2Cleared 510(K)
- K210169Hair Growth Device2Cleared 510(K)
- K203826LaserCap Family of Lasers 300, 224, 120 & 802Cleared 510(K)
- K202983easy Hairfull2Cleared 510(K)
- Show All 77 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Prosthetic DevicesCFR Sub-Part
- Surgical DevicesCFR Sub-Part
- Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
Laser hair growth helmet
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K213025
- 510(k) Type
- Traditional
- Applicant
- Kam Yuen Plastic Products Ltd.
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 5/12/2022
- Days to Decision
- 233 days
- Submission Type
- Summary