LTU-904
- Primary DI
- 09352877000135
- Brand
- LTU-904
- Company
- MEDICAL MANUFACTURERS PTY LTD
- Model
- LTU-904
- Catalog number
- FG00002
- Device description
- Low Level Laser Therapy Device
- Published
- 2023-03-17
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
Product Codes#
| Code | Name |
|---|---|
| NZY | Light, Lymphedema Reduction, Low Energy |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| NZY | Light, Lymphedema Reduction, Low Energy | Physical Medicine | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K030295 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 09352877000135 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|---|---|
| 09352877000135 | 09352877000135 | 9352877000135 |
GMDN Terms#
| Term | Definition |
|---|---|
| Musculoskeletal/physical therapy laser, home-use | An electrically-powered diode laser intended to provide noninvasive laser therapy [e.g., infrared phototherapy, low-level laser therapy (LLLT)] for localized treatment of musculoskeletal conditions (e.g., muscle pain, sports injury, rheumatism, disorders of the joints and soft/connective tissues), improvement of local blood/lymph circulation to facilitate healing/reduce swelling (e.g., lymphoedema therapy), or for non-needle acupuncture. It typically consists of a hand-held applicator designed for transcutaneous delivery of visible red/infrared laser light energy. It is intended to be operated by a patient/layperson in the home, typically under healthcare professional guidance. |
Sterilization Methods#
| Method |
|---|
Regulatory Flags#
- DUNS number
- 759484392
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true