← Product Code [HOH](/submissions/OP/subpart-e%E2%80%94surgical-devices/HOH) · K934494

# SURGITEL (K934494)

_General Scientific Corp. · HOH · Jan 25, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOH/K934494

## Device Facts

- **Applicant:** General Scientific Corp.
- **Product Code:** [HOH](/submissions/OP/subpart-e%E2%80%94surgical-devices/HOH.md)
- **Decision Date:** Jan 25, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.4770
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

Ophthalmic operating spectacles (loupes) are devices that consist of convex lenses or lens systems intended to be worn by a surgeon to magnify the surgical site during ophthalmic surgery.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOH/K934494](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HOH/K934494)

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