FDA UDI
In Commercial Distribution
🇺🇸 United States
Del Sol Blue Light Therapy System
DI: 00850043007012
·
Model: Cordless (US)
·
Hydrafacial LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Del Sol Blue Light Therapy System
- Primary DI
- 00850043007012
- Version / Model
- Cordless (US)
- Catalog Number
- 70392
- Company Name
- Hydrafacial LLC
- Labeler DUNS
- 364134791
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-08-16
- Public Version
- 4
- Public Version Date
- 2023-08-18
- Public Version Status
- Update
- Public Device Record Key
- 4f692acf-d70a-439c-a242-6d3e78d5649a
Device Description
Blue Cordless LED - US
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
- Yes
- 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 |
|---|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 59822 | Skin photodynamic therapy/phototherapy lamp | A portable, mains electricity (AC-powered) lamp intended to emit low-level narrow-band (LLNB) red light (e.g., 600-650nm) and blue light (e.g., 415-440nm) either separately or simultaneously for photodynamic therapy (PDT) applications (with photosensitizing agent) to treat skin disorders such as actinic keratosis and non-melanoma skin cancer, and for phototherapy applications (through modification of skin metabolism) to treat skin complaints such as acne, rosacea and sun spots. It uses light-emitting diodes (LEDs) to produce a heatless light source which may be used for treatment at multiple anatomical sites. It is intended to be used by a healthcare professional in a clinical setting. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00850043007012 | GS1 |
Customer Contacts
- Phone
- 800-603-4996
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K061470 | 000 |