FDA UDI
In Commercial Distribution
🇺🇸 United States
Positively Clear Acne Clearing Blue Light
DI: B5863386
·
Model: BL2
·
Tria Laser Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Positively Clear Acne Clearing Blue Light
- Primary DI
- B5863386
- Version / Model
- BL2
- Catalog Number
- 3386
- Company Name
- Tria Laser Inc
- Labeler DUNS
- 116909762
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2020-07-13
- Public Version
- 3
- Public Version Date
- 2026-01-08
- Public Version Status
- Update
- Public Device Record Key
- 7d09f36e-89a4-4244-ad16-91683189b3c7
Device Description
Positively Clear Acne Clearing Blue Light - Korea
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
- No
- 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 |
|---|---|---|---|---|
| OLP | Over-The-Counter Powered Light Based Laser For Acne | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62414 | Blue-light phototherapy lamp, home-use | A hand-held, battery-powered device designed to emit blue light (e.g., 400-450nm) for phototherapy applications to treat skin diseases such as acne, rosacea, and psoriasis by the patient in the home. 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 | B5863386 | HIBCC |
Customer Contacts
- Phone
- 1-877-321-8742
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K160821 | 000 |