FDA UDI In Commercial Distribution 🇺🇸 United States

LS Pro Systems

DI: 00850061407047 · Model: G264B · 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
00850061407047
Version / Model
G264B
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
09d2832d-9e16-42aa-a217-3abab3161173

Device Description

LS Pro Systems General Blue 264 blue/infrared LED flexi-pad. Intended to deliver light in blue and infrared spectrums to the skin to help kill off acne-causing bacteria and reduces activity in oil-secreting glands; It may also have an anti-inflammatory effect on keratinocytes, the most common cells in the outer layer of the skin and can benefit skin elasticity. 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
ILY Lamp, Infrared, Therapeutic Heating

GMDN Terms

Code Name
62414 Blue-light phototherapy lamp, home-use

Identifiers

Type ID
Primary 00850061407047