← Product Code [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX) · K002510 # SMARTLENS (K002510) _Odc Ophthalmic Development Co. AG · HKX · Oct 18, 2000 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K002510 ## Device Facts - **Applicant:** Odc Ophthalmic Development Co. AG - **Product Code:** [HKX](/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX.md) - **Decision Date:** Oct 18, 2000 - **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/K002510](https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K002510) **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 as:** FDA Device Explorer (Innolitics), https://fda.innolitics.com/submissions/OP/subpart-b%E2%80%94diagnostic-devices/HKX/K002510