FDA UDI
In Commercial Distribution
🇺🇸 United States
VISULAS
DI: 04049471091489
·
Model: VISULAS yag
·
Carl Zeiss Meditec AG
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- VISULAS
- Primary DI
- 04049471091489
- Version / Model
- VISULAS yag
- Company Name
- Carl Zeiss Meditec AG
- Labeler DUNS
- 314594680
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-12
- Public Version
- 1
- Public Version Date
- 2026-01-20
- Public Version Status
- New
- Public Device Record Key
- 68f1cd85-565d-4d0d-9c82-07024f103e9d
Device Description
VISULAS yag is intended for use in photodisrupting ocular tissue in the treatment of diseases of the eye, including Posterior capsulotomy, Iridotomy and Posterior Membranectomy. This device is for Prescription Use (Rx) only.
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 |
|---|---|---|---|---|
| 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 | 04049471091489 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K230350 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Dimension of laser console: 201 mm x 230 mm x 290 mm |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 15 – 30 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 0 – 90 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 0 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal