# K023481: Microvision Scleral Buckling Components

- Pathway: 510(k) (Traditional)
- Applicant: Microvision, Inc.
- Decided: Jan 8, 2003 after 83 days
- Product code: HQX (Implant, Orbital, Extra-Ocular)
- Device class: 2
- Regulation: 21 CFR 886.3340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K780987 (1978). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K950806: Solid Dilicone Implants, Sdilicone Sponge Implants, Mira, Inc. (1996) Summary page 1.
- K832481: Scleral Buckling Implants Dif/Types, Storz Instrument Co. (1983) Summary page 1.
- K950599: Stors Scleral Sponge II (Lincoff Design), Storz Ophthalmics, Inc. (1995) Summary page 1.
- K875014: Labtician Retinal Implants, Labtician Products, Inc. (1988) Summary page 1.

## Indications for use
The MicroVision Scleral Buckling Components are solid silicone and silicone:sponge implants intended for intrascleral and episcleral buckling in the surgical treatment of retinal detachment.

Source page: https://510kreport.com/device/K023481
Methodology: https://510kreport.com/methodology