# K110951: 27+ Ultravit Probe, 27+ Flex-Tip Laser Probe, 27+ Endoilluminator Probe, 27+ Valved Entry System, 27+ Infusion Cannula

- Pathway: 510(k) (Traditional)
- Applicant: Alcon Research, Ltd.
- Decided: Oct 17, 2011 after 196 days
- Product code: HQB (Photocoagulator And Accessories)
- Device class: 2
- Regulation: 21 CFR 886.4690
- 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: 7 generations back to K933880 (1994). 41 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093305: Enhanced Ultra Vit Probe, Alcon Research, Ltd. (2010) Summary page 1.
- K062624: Next Generation Laser, Alcon Laboratories (2007) Summary page 1.
- K063583: Alcon Vision System, Alcon (2008) Summary page 1.
- K101285: Constellation Vision System, Alcon Manufacturing, Ltd. (2010) Summary page 1.
- (no number) 25Ga Valved Entry System: named in the summary without a submission number
- (no number) 25Ga Infusion Cannula: named in the summary without a submission number

## Most influential descendants
- K170520: HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ (2017), 1 descendant of its own
- K242184: Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator (8065000253); Alcon 27+ DS Endoilluminator (8065000256); (2024), 0 descendants of its own
- K220030: Vista Ophthalmics Vitrectomy Probe (2022), 0 descendants of its own

## Recalls of this device
- Sep 15, 2025 · Class II · Z-0581-2026: XXX

## Indications for use
The 27+ Retina Instrument Set instruments, along with the Constellation Vision System or Next Generation Laser System, are intended for the following uses: 27+ UltraVit Probe * Vitreous aspiration & cutting. * Membrane cutting & aspiration. * Lens removal. * Dissect tissue in the eye. (The 27+ UltraVit Probe is intended to be used with the Alcon Constellation Vision System.) 27+ Flex-Tip Laser Probe * Retinal photocoagulation, panretinal photocoagulation and intravitreal photocoagulation of vascular and structural abnormalities of the retina and choroid including: o Proliferative and nonproliferative retinopathy (including diabetic); o Choroidal neovascularization secondary to age-related macular degeneration; o Retinal tears and detachments; o Macular edema; o Retinopathy of prematurity; o Choroidal neovascularization; o Leaking microaneurysms. * Iridotomy/iridectomy for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and Refractory Glaucoma. * Trabeculoplasty for treatment of Chronic/Primary Open Angle Glaucoma (COAG,POAG) and refractory Glaucoma. * And other laser treatments including: o Internal sclerostomy; o Lattice degeneration; o Central and Branch Retinal Vein Occlusion; o Suturelysis; o Vascular and pigmented skin lesions. (The 27+ Flex-Tip Probe is intended to be used with 532 nm laser systems such as the Alcon Constellation Vision System, or the Alcon PurePoint Laser System.) 27+ Endoilluminator Probe * Endoillumination (The 27+ Endoilluminator Probe is intended to be used with the Alcon Constellation Vision System) 27+ Valved Entry System * Scleral incision * Cannulae for posterior segment instrument access * Venting (of valved cannulae) 27+ Infusion Cannula * Posterior segment infusion (liquid or gas)

Source page: https://510kreport.com/device/K110951
Methodology: https://510kreport.com/methodology