# K970319: Ocular Conformer

- Pathway: 510(k) (Traditional)
- Applicant: Xavier A. Guerra, Ocularist, Inc.
- Decided: Jul 7, 1997 after 160 days
- Product code: HQN (Conformer, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.3130
- 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 Conformer, is fabricated for the needs of a specific patient. Each is uniquely designed, fabricated, and fitted post-enucleation/evisceration surgery, to maintain i correct eye lid/socket configuration.. In.the other cases, to - - correct deformities of the eyelids, and/or socket. They are also fitted in a necessarily, sequential, increasing size, for infants afflicted with anophthalmia, or micro-ophthalmia, as well as patients with trauma or other socket and eyelid anomalies. proper expansion therapy, with the use of sequential, increasing size conformers, is ess§nt1a1 in promoting bony orbit, orbital fascia, and eyelid development in infants and children.

Source page: https://510kreport.com/device/K970319
Methodology: https://510kreport.com/methodology