FDA UDI
In Commercial Distribution
🇺🇸 United States
LS Pro Systems
DI: 00850061407214
·
Model: F122-SI
·
WELLNESS WITHOUT LIMITS LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LS Pro Systems
- Primary DI
- 00850061407214
- Version / Model
- F122-SI
- Company Name
- WELLNESS WITHOUT LIMITS LLC
- Labeler DUNS
- 020287489
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-05-09
- Public Version
- 1
- Public Version Date
- 2024-05-17
- Public Version Status
- New
- Public Device Record Key
- bbbfa77f-950d-4e1f-a4dc-f77d49d4b597
Device Description
LS Pro Systems Face Pad in Silicone 122 blue/red/ LED flexi-pad. Intended to emit both red and blue light for the treatment of a facial skin conditions and help with mood, circadian rhythm, sleep, and relaxation. It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin. Promotes circulation at the skin level and can increase elasticity/collagen. Must be used with LS power controller.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 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 | 00850061407214 | GS1 |