FDA UDI
In Commercial Distribution
🇺🇸 United States
LightLas 532/670
DI: 04712826770659
·
Model: ML0010
·
LIGHTMED CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- LightLas 532/670
- Primary DI
- 04712826770659
- Version / Model
- ML0010
- Company Name
- LIGHTMED CORPORATION
- Labeler DUNS
- 657731175
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2021-11-10
- Public Version Status
- Update
- Public Device Record Key
- 63882a2d-5da0-44f1-8742-9b4a7d86b426
Device Description
This laser system is included one laser console, laser delivery unit and ophthalmic powered table. There are 3 boxs individually.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- 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
- Yes
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62197 | Ophthalmic solid-state laser system | An electrically-powered device assembly with a solid-state laser (exited glass/crystal rod), that might be designed to optionally utilize the diode pump laser as a direct therapeutic laser, intended for ophthalmic surgery (e.g., photocoagulation, photodisruption) and/or photostimulation of retinal pigment epithelium (RPE) cells to reverse macular degeneration. It might include a built-in slit lamp, a dosimetry sensor, and/or frequency doubling technology, however it does not include femtosecond pulsing or fundus imaging technology. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04712826770659 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K103547 | 000 |