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
- 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
- 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)
- K232356Laser Cap, Model: Hat-012Cleared 510(K)
- K231321Nooance Led And Laser Helmet2Cleared 510(K)
Show All 98 Submissions
- OZCOver The Counter Thermal Treatment For Acne.2Product Code
- Subpart F—Therapeutic DevicesCFR Sub-Part
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
HIGHERDOSE Red Light Hat (HG-120K)
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K242363
- 510(k) Type
- Traditional
- Applicant
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Country
- China
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/20/2024
- Days to Decision
- 103 days
- Submission Type
- Summary