FDA UDI
In Commercial Distribution
🇺🇸 United States
LED Light Therapy Mask-GYH
DI: 16978368600082
·
Model: RB-008
·
Shenzhen Rainbow Technology Co.,Ltd
Product Codes
3
GMDN Terms
1
Identifiers
2
Pkg Device Count
10
Basic Information
- Brand Name
- LED Light Therapy Mask-GYH
- Primary DI
- 16978368600082
- Version / Model
- RB-008
- Company Name
- Shenzhen Rainbow Technology Co.,Ltd
- Labeler DUNS
- 550663864
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 10
- Record Status
- Published
- Publish Date
- 2025-06-05
- Public Version
- 1
- Public Version Date
- 2025-06-13
- Public Version Status
- New
- Public Device Record Key
- fcd154fd-8ba2-43fb-bb93-df531468cee1
Device Description
Red+Infrared light:Treatment of full-face wrinkles. Red light:Treatment of full-face wrinkles. Blue light:Treatment of mild to moderate inflammatory acne.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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
- Yes
- Has Expiration Date
- Yes
- 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 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | General, Plastic Surgery | 878.4810 | 2 |
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62202 | Blue/red/infrared phototherapy lamp | A portable, electrically-powered device designed to emit blue light, red light, and infrared radiation (heating effect) for phototherapy treatment of mild skin disorders (e.g., mild acne), superficial skin wounds, musculoskeletal symptoms (e.g., pain, spasm, stiffness), and/or for cosmetic skin rejuvenation. It may have various designs (e.g., hand-held, book-like, flexible pad for adapting to body areas) and is intended for use in the home or a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 16978368600082 | GS1 | ||||
| Unit of Use | 06978368600085 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K243423 | 000 |