# K193376: Visalis V500, Visalis S500

- Pathway: 510(k) (Traditional)
- Applicant: Carl Zeiss Meditec, AG
- Decided: Jun 15, 2020 after 193 days
- Product code: HQC (Unit, Phacofragmentation)
- Device class: 2
- Regulation: 21 CFR 886.4670
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K933880 (1994). 61 ancestors in all.
No later device cites it as a predicate yet.
0 of 62 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141065: Constellation Vision System, Alcon Research, Ltd. (2014) Summary page 5.

## Indications for use
The VISALIS V500 and VISALIS S500 Surgical System is indicated for surgical treatment of the anterior segment of the eye by performing irrigation, irrigation /suction, phacoemulsification of the crystalline lens, anterior vitrectomy and coagulation techniques using bipolar diathermy. The VISALIS V500 is indicated for use in vitreo-retinal surgery such as retinal detachment and other pathologies of the vitreous body and the posterior segment of the human eye. ACCESSORIES: ULITE PHACO HANDPIECE This active re-usable device is an accessory for ZEISS phaco systems. It has been designed to emulsify and aspirate the eye lens during human eye surgery by phacoemulsification technique. DIATHERMY PROBES The DIATHERMY PROBES are active re-usable device is an accessory for ZEISS phaco systems. It has been designed to cauterize (stop bleeding) small vessels during human eye surgery on the anterior segment. ENDODIATHERMY PROBES This active single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to cauterize (stop bleeding) small vessels in the eye bulb and/or on the retina using a high frequency electrical current (generated from the equipment to which it is connected) passed through tissue from one electrode to another. ENDOILLUMINATION PROBES This single use device is an accessory of ZEISS phaco systems with posterior segment functionality. It has been designed to internally illuminate the eye bulb transmitting the light emitted by a xenon lamp.

Source page: https://510kreport.com/device/K193376
Methodology: https://510kreport.com/methodology