FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CryoGlow (FW3XXXX)
K Number: K242796
·
Decision Nov 27, 2024
Classifications
1
FEI Numbers
126
Registration Numbers
126
Same Product Code
152
Applicant Total
1
Review Days
72
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Basic Information
- Device Name
- CryoGlow (FW3XXXX)
- K Number
- K242796
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sharkninja Operating, LLC
- Date Received
- September 16, 2024
- Decision Date
- November 27, 2024
- Product Code
- OHS
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | FDA class 2 | General, Plastic Surgery |
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