# K013402: Visulas 532S

- Pathway: 510(k) (Special)
- Applicant: Carl Zeiss, Inc.
- Decided: Nov 14, 2001 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K925642 (1993). 1 ancestor in all.
19 later devices descend from it; 5 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925642: Zeiss Diode-Pumped Solid State Laser, Carl Zeiss, Inc. (1993) Summary page 2.

## Most influential descendants
- K043236: Frequency Doubled ND: Yag Photocoagulator, Model Vitra (2005), 6 descendants of its own
- K100035: Model Visulas 532S Laser with the Vite Option (2010), 4 descendants of its own
- K072823: Merilas 532A (2007), 4 descendants of its own
- K091064: Navilas Laser System (2009), 3 descendants of its own
- K070776: Supra Ophthalmic Laser Photocoagulator (2007), 3 descendants of its own

## Recalls of this device
- Jun 3, 2004 · Not classified · Z-1066-04: The coating of laser mirrors in a defined manufacturing lot of the Visulink 532/U devices may partially tear open and loosen from the base plate. The mirror may misdirect the laser beam to an unintend

## Indications for use
The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.

Source page: https://510kreport.com/device/K013402
Methodology: https://510kreport.com/methodology