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#
Shark CryoGlow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
Shark CryoGlow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
Shark CryoGlow - The Shark CryoGlow LED Facemask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
Shark CryoGlow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark™ DePuffi™ - The Shark™ DePuffi™ is intended for use as follows: Instaheat Treatment: Massage in slow, outward strokes to boost circulation for more radiant skin. Instachill Treatment: Massage in slow upward strokes to contour face and reduce puffiness. Massage under eyes for an instantly refreshed and awakened look. Body Treatment: Massage anytime, anywhere for muscle relaxation. Massage down neck to help support movement of lymphatic fluid.
2026-06-02
Shark™ DePuffi™ - The Shark™ DePuffi™ is intended for use as follows: Instaheat Treatment: Massage in slow, outward strokes to boost circulation for more radiant skin. Instachill Treatment: Massage in slow upward strokes to contour face and reduce puffiness. Massage under eyes for an instantly refreshed and awakened look. Body Treatment: Massage anytime, anywhere for muscle relaxation. Massage down neck to help support movement of lymphatic fluid.
2026-06-02
Shark CryoGlow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark™ DePuffi™ - The Shark™ DePuffi™ is intended for use as follows: Instaheat Treatment: Massage in slow, outward strokes to boost circulation for more radiant skin. Instachill Treatment: Massage in slow upward strokes to contour face and reduce puffiness. Massage under eyes for an instantly refreshed and awakened look. Body Treatment: Massage anytime, anywhere for muscle relaxation. Massage down neck to help support movement of lymphatic fluid.
2026-06-02
Shark FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2026-06-02
Shark CryoGlow - The Shark CryoGlow Mask is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
2026-06-02
FacialPro Glow - FacialPro™ Glow is facial device, designed to help you achieve professional level results in the comfort of your own home. Our skincare exfoliation and Depuffi™ Technology has been developed as an all-in-one system to enhance your existing routine.
2025-09-18
Shark - The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treatfine lines and wrinkles.
2025-01-27