K242796
- 510(k) number
- K242796
- Device name
- CryoGlow (FW3XXXX)
- Applicant
- Sharkninja Operating, LLC MA · US
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2024-11-27
- Date received
- 2024-09-16
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
510(k) Summary (official FDA PDF): K242796.pdf
Official FDA record: K242796
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.