← Product Code [HQG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG) · K852403

# AURALITE II (K852403)

_Aura Lens Products · HQG · Aug 20, 1985 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K852403

## Device Facts

- **Applicant:** Aura Lens Products
- **Product Code:** [HQG](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG.md)
- **Decision Date:** Aug 20, 1985
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.5844
- **Device Class:** Class 1
- **Review Panel:** Ophthalmic

## Regulatory Identification

A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K852403](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/HQG/K852403)

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