FDA UDI
In Commercial Distribution
🇺🇸 United States
WaveLight
DI: 00380659984372
·
Model: 1023
·
Alcon Laboratories, Inc.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- WaveLight
- Primary DI
- 00380659984372
- Version / Model
- 1023
- Catalog Number
- 8065998437
- Company Name
- Alcon Laboratories, Inc.
- Labeler DUNS
- 008018525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-03-12
- Public Version
- 2
- Public Version Date
- 2026-02-26
- Public Version Status
- Update
- Public Device Record Key
- 71e6683b-5efd-4687-88c5-9af1f9991e31
Device Description
Diagnostic device to perform non-contact measurements of the corneal tomography, anterior chamber parameter, pupil diameter, axial length, and optical aberrations of the patient’s eye.
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 | |
| MXK | Device, Analysis, Anterior Segment | Ophthalmic | 886.1850 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45729 | Ophthalmic anterior segment multiple dimension meter | An electrically-powered, tabletop, ophthalmic device intended to measure and evaluate multiple properties of the anterior segment (i.e., cornea, iris, pupil, anterior chamber, lens) for diagnosis and/or management of a condition, and/or surgical planning. Also referred to as an anterior segment analyser, a biometer or tono-refracto-kerato-pachymeter, it typically employs techniques involving light (e.g., optical low coherence reflectometry or tomography), Scheimpflug photography, or Placido imaging; it is not an ultrasound-dedicated device. It may be designed for connection to an off-the-shelf computer for control and/or results analysis. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00380659984372 | GS1 |