← Product Code [LWL](/submissions/OP/subpart-e%E2%80%94surgical-devices/LWL) · P910071

# ADATOMED SILICONE OIL OP5000 (P910071)

_Bausch & Lomb · LWL · Nov 4, 1994 · Ophthalmic · APPR_

**Canonical URL:** https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-e%E2%80%94surgical-devices/LWL/P910071

## Device Facts

- **Applicant:** Bausch & Lomb
- **Product Code:** [LWL](/submissions/OP/subpart-e%E2%80%94surgical-devices/LWL.md)
- **Decision Date:** Nov 4, 1994
- **Decision:** APPR
- **Regulation:** 21 CFR 886.4275
- **Device Class:** Class 3
- **Review Panel:** Ophthalmic
- **Attributes:** Expedited Review

## Regulatory Identification

An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.

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**Source:** [https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-e%E2%80%94surgical-devices/LWL/P910071](https://fda.innolitics.com/submissions/OPHTHALMIC/subpart-e%E2%80%94surgical-devices/LWL/P910071)

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