FDA UDI
In Commercial Distribution
🇺🇸 United States
Norlase LEAF photocoagulator
DI: 05700002165442
·
Model: N005-9010-Z
·
Norlase ApS
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Norlase LEAF photocoagulator
- Primary DI
- 05700002165442
- Version / Model
- N005-9010-Z
- Company Name
- Norlase ApS
- Labeler DUNS
- 305483903
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-12-06
- Public Version
- 1
- Public Version Date
- 2023-12-14
- Public Version Status
- New
- Public Device Record Key
- 9ed29a75-a133-4bba-aa4d-fa4d63b1f8d5
Device Description
The Norlase LEAF Photocoagulator is intended to be used in ophthalmic laser procedures including retinal and macular photocoagulation, iridotomy, and trabeculoplasty
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- Yes
- 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 |
|---|---|---|---|---|
| HQF | Laser, Ophthalmic | Ophthalmic | 886.4390 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 62161 | Ophthalmic diode laser system | An electrically-powered device assembly in which input energy is used to excite a diode to emit a low-power and/or high-power therapeutic laser beam intended for ophthalmic surgery (e.g., ocular incisions, ocular photocoagulation, iridectomy, vitrectomy). Some types may also include an air pump to disperse subretinal fluid in certain procedures (e.g. retinal detachment repair). The laser utilizes a diode/semiconductor chip (as the active medium); 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 | 05700002165442 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K190083 | 000 |