# K970320: Scleral Shell

- Pathway: 510(k) (Traditional)
- Applicant: Xavier A. Guerra, Ocularist, Inc.
- Decided: Jul 7, 1997 after 160 days
- Product code: HQT (Shell, Scleral)
- Device class: 2
- Regulation: 21 CFR 886.3800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Custom Scleral Cover Shell; "is an ocular prosthesis, (artificial eye), fitted over a deformed, or disfigured blind eye, or over an eviscerated globe, for a specific patient. Scleral Cover Shells are also indicated for patients with Microphthalmia, Phthisis Bulbi, or other types of eye deformities. In cases of infants and children with microphthalmia, and /or anophthalmia, the orbital fascia, bony orbit, and palpebral fissures, will be provided with the volume and surface area necessary to develop more normally, thus avoiding the complication of future deformities and possible corrective surgery.

Source page: https://510kreport.com/device/K970320
Methodology: https://510kreport.com/methodology