FDA UDI
In Commercial Distribution
🇺🇸 United States
WAVELIGHT EX500 EXCIMER LASER
DI: 00380659907944
·
Model: 8065990794
·
Alcon Laboratories, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WAVELIGHT EX500 EXCIMER LASER
- Primary DI
- 00380659907944
- Version / Model
- 8065990794
- Catalog Number
- 8065990794
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2014-09-24
- Public Version
- 4
- Public Version Date
- 2022-11-07
- Public Version Status
- Update
- Public Device Record Key
- 35057b0a-3a06-4173-9d96-f5c655d80948
Device Description
WAVELIGHT EX500 EX LASER US
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
- 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 |
|---|---|---|---|---|
| LZS | Excimer Laser System | Unknown | 3 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17702 | Ophthalmic excimer laser system | A mains electricity (AC-powered) device assembly in which input energy is used to excite an excimer gas to emit a high-power laser beam intended for corneal ablation (i.e., photorefractive keratectomy) and other ophthalmologic procedures (e.g., surgical creation of a communication between the lacrimal sac and the nasal cavity). It includes a light source and controls/foot-switch, and is typically coupled to a biomicroscope slit lamp or to an indirect ophthalmoscope by a flexible fibreoptic cable. 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 | 00380659907944 | GS1 |
Customer Contacts
- Phone
- +1(800)-862-5266
- [email protected]
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Weight | 1200 | Pound |