← Product Code [HPS](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPS) · K940373

# OPHTHALMIC CRYO UNIT (K940373)

_Dutch Ophthalmic USA, Inc. · HPS · Jul 18, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPS/K940373

## Device Facts

- **Applicant:** Dutch Ophthalmic USA, Inc.
- **Product Code:** [HPS](/submissions/OP/subpart-e%E2%80%94surgical-devices/HPS.md)
- **Decision Date:** Jul 18, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4170
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A cryophthalmic unit is a device that is a probe with a small tip that becomes extremely cold through the controlled use of a refrigerant or gas. The device may be AC-powered. The device is intended to remove cataracts by the formation of an adherent ice ball in the lens, to freeze the eye and adjunct parts for surgical removal of scars, and to freeze tumors.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPS/K940373](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HPS/K940373)

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