510(k) K242796
K242796 is an FDA 510(k) premarket notification submitted by Sharkninja Operating, LLC for the device "CryoGlow (FW3XXXX)". The FDA issued a decision of Substantially Equivalent on November 27, 2024. The device falls under product code OHS (Light Based Over The Counter Wrinkle Reduction), a Class II device regulated under 21 CFR 878.4810.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 27, 2024
- Date Received
- September 16, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Based Over The Counter Wrinkle Reduction
- Device Class
- Class II
- Regulation Number
- 878.4810
- Review Panel
- SU
- Submission Type
Use of light based treatment to reduce wrinkles on the body in general or specific anatomical locations depending on the information provided.