# K153168: Bi-Blade Vitrectomy Cutter

- Pathway: 510(k) (Special)
- Applicant: Medical Instrument Development Laboratories
- Decided: Apr 29, 2016 after 179 days
- Product code: HQE (Instrument, Vitreous Aspiration And Cutting, Ac-Powered)
- Device class: 2
- Regulation: 21 CFR 886.4150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K932669 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102222: Ultimate Vit Enhamcer (Uve), Medical Instrument Development Laboratories, Inc. (2011) Summary page 4.

## Most influential descendants
- K252052: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (2026), 0 descendants of its own

## Indications for use
The UVE and MID Labs Bi-Blade Vitrectomy Cutter labeled for use with the UVE are used to remove vitreous and intraocular tissue. The UVE can only be used with the MID Labs Bi-Blade Vitrectomy Cutter. The UVE is used in conjunction with ophthalmic surgical equipment as a Host system (typically phacoemulsification or vitreoretinal surgical equipment).

Source page: https://510kreport.com/device/K153168
Methodology: https://510kreport.com/methodology