FDA UDI
In Commercial Distribution
🇺🇸 United States
LIGHTFORCE
DI: 00190446897842
·
Model: PRD-000424-010-01-L-G5
·
DJO, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- LIGHTFORCE
- Primary DI
- 00190446897842
- Version / Model
- PRD-000424-010-01-L-G5
- Company Name
- DJO, LLC
- Labeler DUNS
- 081840873
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-01-14
- Public Version
- 1
- Public Version Date
- 2025-01-22
- Public Version Status
- New
- Public Device Record Key
- 7a479646-2831-45fe-ba48-7d9173150800
Device Description
Trade-In 600um BHP LightForce - More than 5yrs old
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- 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 |
|---|---|---|---|---|
| ILY | Lamp, infrared, therapeutic heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 63540 | Musculoskeletal/physical therapy laser beam guide, transcutaneous | A noninvasive, hand-held device intended to be connected to a laser unit intended for musculoskeletal therapy [e.g., infrared phototherapy laser, low-level laser therapy (LLLT) system] to deliver visible red/infrared laser light energy to the skin-surface for localized treatment of underlying musculoskeletal pain/injury (e.g., muscle pain, sports injury, rheumatism) and to improve blood circulation in the treated areas to facilitate healing. It is a handpiece-like device with fibreoptic materials and may include a manual massager as an adjunct to laser energy therapy. It is intended to be operated by a healthcare professional exclusively in a clinical setting. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00190446897842 | GS1 |