← Product Code [HOI](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI) · K943613

# NIL (K943613)

_Sing Wah International Enterprises , Ltd. · HOI · Sep 21, 1994 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K943613

## Device Facts

- **Applicant:** Sing Wah International Enterprises , Ltd.
- **Product Code:** [HOI](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI.md)
- **Decision Date:** Sep 21, 1994
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5840
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K943613](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HOI/K943613)

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