Vitra 2
510(k) K191962
Active
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK191962 | Date5 Dec 2019 | StatusActive |
| European Union | CE/MDD EUDAMED | Number— | Date— | StatusActive |
Official records
Across registries
- FDA 510(k) K191962 decided 5 Dec 2019 Active
- EUDAMED Active
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- European Union
- United States
Specification
- 510(k) Number
- FDA product code
- GEX
- Device class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory committee
- General, Plastic Surgery
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Vitra 2 is a retinal photocoagulation laser designed for ophthalmic use. It delivers precise laser treatment to the retina, primarily for managing conditions such as diabetic retinopathy, age-related macular degeneration, and retinal vascular abnormalities. This device operates at a wavelength of 532 nm, enabling targeted photocoagulation with controlled energy delivery. Its classification aligns with ophthalmic laser systems used in surgical and therapeutic retinal interventions.
The Vitra 2 is supplied as a standalone system compatible with Haag-Streit and Zeiss slit lamps, facilitating integration into existing ophthalmic examination setups. It is intended for use in clinical environments, including outpatient clinics and hospital ophthalmology departments, where retinal procedures are performed. The device is not described as single-use or reusable in the specifications, though its sterility and maintenance protocols would follow standard clinical laser device guidelines. No explicit MRI safety information is provided, and its regulatory authorisations include FDA 510(k) clearance under the General, Plastic Surgery advisory committee and compliance with the MDD (Medical Device Directive).
Devices cleared under K191962
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VITRA 2 | VITRA 2 | 03700542625569 | — | On the market |
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