CryoGlow (FW3XXXX)
Sharkninja Operating, LLC
SHARKNINJA OPERATING LLC
FDA Registration(s)
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013738756 | 3013738756 | SHARKNINJA OPERATING LLC | 1 | N | 2026-01-01 | 89 A St #100 Needham MA US 02494 |
Registered Device Listings
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 334820 | 1929635491 | K242796 | CryoGlow (FW3XXXX) | OHS | 2024-11-27 |
| 334820 | 1329065812 | ||||
| 334820 | 1629601817 |
Product Codes Associated With Registrations
| Product code | Registration listing records | Latest decision |
|---|---|---|
| OHS | 1 | 2024-11-27 |
PMN
GUDID
FacialPro Glow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles. The Model Number is FW312.
2025-09-18
Shark - The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2025-01-27