Identity
- Trade Name
- Positively Clear Acne Clearing Blue Light FDA UDI
- Generic Name
- Blue-light phototherapy lamp, home-use FDA UDI
- Device Name
- Positively Clear Acne Clearing Blue Light - Korea FDA UDI
- Model / Reference
- BL2 FDA UDI
- Description
- Positively Clear Acne Clearing Blue Light - Korea FDA UDI
Identifiers
- Catalog Number
- 3386 FDA UDI
- Primary DI / UDI-DI
- B5863386 FDA UDI
- 510(k) Number
- K160821 FDA UDI
- FDA Product Code
- OLP FDA UDI
- GMDN Term
- Blue-light phototherapy lamp, home-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Blue-light phototherapy lamp, home-use
Positively Clear Acne Clearing Blue Light by Tria Laser Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Blue-light phototherapy lamp, home-use.
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- ESPADA 2 — FOREO INC · Class II
- ESPADA 2 — FOREO INC · Class II
- CLEANE — Medicon Co., Ltd. · Class II
Cleared under the same submission
K160821 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Tria Laser Inc
Sources (1)
- FDA UDI 7d09f36e-89a4-4244-ad16-91683189b3c7 36 fields · synced May 30, 2026