FDA UDI
In Commercial Distribution
🇺🇸 United States
Omnilux CLEAR
DI: 05060534510234
·
Model: TN2112
·
I-SMART DEVELOPMENTS LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Omnilux CLEAR
- Primary DI
- 05060534510234
- Version / Model
- TN2112
- Catalog Number
- 135-OC
- Company Name
- I-SMART DEVELOPMENTS LIMITED
- Labeler DUNS
- 223616320
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-07-05
- Public Version
- 1
- Public Version Date
- 2021-07-13
- Public Version Status
- New
- Public Device Record Key
- 48a154a0-b93d-416c-bc38-b09e1a0a14bc
Device Description
Over-The-Counter Powered Light Based Laser For Acne- Omnilux CLEAR branded
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
- 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 |
|---|---|---|---|---|
| 62116 | Red/blue light phototherapy unit | A portable electrically-powered device intended to emit both red and blue light for the treatment of a facial skin condition (e.g., acne, hyperpigmentation) by the patient in the home. It includes integral lights with a controller/controlling interface (to pair with an off-the-shelf computer/smartphone), and may be available in a variety of forms (e.g., a face-worn light mask with controller, hand-held light unit). It is not intended for use with a photosensitizing agent. 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 | 05060534510234 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K210948 | 000 |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -5 – 55 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 20 – 85 Percent (%) Relative Humidity