← Product Code [HQX](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX) · K950599

# STORS SCLERAL SPONGE II (LINCOFF DESIGN) (K950599)

_Storz Ophthalmics, Inc. · HQX · Mar 2, 1995 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K950599

## Device Facts

- **Applicant:** Storz Ophthalmics, Inc.
- **Product Code:** [HQX](/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX.md)
- **Decision Date:** Mar 2, 1995
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.3340
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

An extraocular orbital implant is a nonabsorbable device intended to be implanted during scleral surgery for buckling or building up the floor of the eye, usually in conjunction with retinal reattachment. Injectable substances are excluded.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K950599](https://fda.innolitics.com/submissions/OP/subpart-d%E2%80%94prosthetic-devices/HQX/K950599)

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