← Product Code [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) · K802419

# AO NON-CONTACT II TONOMETER (K802419)

_American Optical Corp. · HKX · Nov 12, 1980 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K802419

## Device Facts

- **Applicant:** American Optical Corp.
- **Product Code:** [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX.md)
- **Decision Date:** Nov 12, 1980
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 886.1930
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A tonometer and accessories is a manual device intended to measure intraocular pressure by applying a known force on the globe of the eye and measuring the amount of indentation produced (Schiotz type) or to measure intraocular tension by applanation (applying a small flat disk to the cornea). Accessories for the device may include a tonometer calibrator or a tonograph recording system. The device is intended for use in the diagnosis of glaucoma.

---

**Source:** [https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K802419](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K802419)

**Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact).

**Cite:** Innolitics at https://innolitics.com