FDA.report

Shark

Primary DI
00622356086912
Brand
Shark
Company
SharkNinja Operating LLC
Model
CryoGlow
Device description
The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
Published
2025-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
OHSLight Based Over The Counter Wrinkle Reduction

Product Code Classifications

CodeDeviceSpecialtyClass
OHSLight Based Over The Counter Wrinkle ReductionGeneral, Plastic Surgery2

Premarket Submissions

SubmissionSupplement
K242796000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K242796000CryoGlow (FW3XXXX)Sharkninja Operating, LLC2024-11-27OHS

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00622356086912PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00622356086912006223560869126223560869120622356086912

GMDN Terms

TermDefinition
Red/blue light phototherapy unitA portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. This is a single-patient, reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
144444333
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00622356642804FacialPro GlowFH3202025-09-18

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