FDA UDI
In Commercial Distribution
🇺🇸 United States
Shark
DI: 00622356086912
·
Model: CryoGlow
·
SharkNinja Operating LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Shark
- Primary DI
- 00622356086912
- Version / Model
- CryoGlow
- Company Name
- SharkNinja Operating LLC
- Labeler DUNS
- 144444333
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-27
- Public Version
- 1
- Public Version Date
- 2025-02-04
- Public Version Status
- New
- Public Device Record Key
- 223a01c3-4b81-4b80-9b10-f52ab5ed834f
Device Description
The CryoGlow is intended for the treatment of mild to moderate inflammatory acne and to treat fine lines and wrinkles.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62116 | Red/blue light phototherapy unit | A 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00622356086912 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K242796 | 000 |