FDA UDI
In Commercial Distribution
🇺🇸 United States
Phoenix Thera-Lase system
DI: 00860012594955
·
Model: 70W
·
PHOENIX THERA-LASE SYSTEMS, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Phoenix Thera-Lase system
- Primary DI
- 00860012594955
- Version / Model
- 70W
- Company Name
- PHOENIX THERA-LASE SYSTEMS, LLC
- Labeler DUNS
- 079869313
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-26
- Public Version
- 1
- Public Version Date
- 2025-01-03
- Public Version Status
- New
- Public Device Record Key
- e9e71240-a9ef-4561-99d2-ca828e0ffaed
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
- 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
- No
- 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 |
|---|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | Physical Medicine | 890.5500 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60409 | Musculoskeletal/physical therapy laser, professional | An electrically-powered diode laser intended to provide non-surgical laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle/joint pain, sports injury), improvement of local blood circulation in the treated areas to facilitate healing, or for non-needle acupuncture. It typically consists of a control unit which may be mounted on a mobile trolley, a foot-switch, and a connected applicator/beam guide designed for intra-orifice (e.g., intravaginal) or transcutaneous delivery of visible red/infrared laser light energy/heat. It is intended to be operated exclusively by a healthcare professional. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860012594955 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151521 | 000 |