FDA UDI
In Commercial Distribution
🇺🇸 United States
Professional Blue
DI: 00851478007110
·
Model: DPA-006A
·
QUASAR BIO-TECH INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Professional Blue
- Primary DI
- 00851478007110
- Version / Model
- DPA-006A
- Catalog Number
- DPA-006A
- Company Name
- QUASAR BIO-TECH INC.
- Labeler DUNS
- 849862912
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-19
- Public Version
- 4
- Public Version Date
- 2020-07-07
- Public Version Status
- Update
- Public Device Record Key
- 6c9dc862-68f0-4a6c-9c63-7341b5ea4372
Device Description
The Quasar Professional Blue Light Therapy device will help your clients gain control over blemishes and occasional breakouts. Intended for use with hormonal acne or acne vulgaris, the light effectively eliminates the acne bacteria that causes breakouts.
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
- No
- 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 |
|---|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | General, Plastic Surgery | 878.4810 | 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 | 00851478007110 | GS1 |
Customer Contacts
- Phone
- 941-306-5812
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K093963 | 000 |