APPLANATION TONOMETER— 510(k) K023676

Substantially Equivalent

Optilasa, S.L.

FDA 510(k) clearance K023676 for APPLANATION TONOMETER, Substantially Equivalent on 2003-04-24. Applicant: Optilasa, S.L.. Device class: 2.

Clearance details

Applicant: Optilasa, S.L.
Product code: Code HKX
Device class: Class 2
Regulation: 21 CFR 886.1930
Advisory panel: Ophthalmic
Date received: 2002-11-01
Decision date: 2003-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Madrid, ES

Download summary PDF View on FDA.gov ↗

Recent devices under product code HKX

K253039 — AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA2025-11-07
K223739 — VS Tabletop Tonometer2023-11-08
K190382 — Intraocular Pressure Tonometer EASYTON2019-12-06
K181260 — MiiS Horus Scope DPT 1002019-06-21
K181143 — Keeler TonoCare Tonometer2019-02-08

Data sourced from openFDA. This site is unofficial and independent of the FDA.