510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K023676Substantially Equivalent

Applanation Tonometer

Optilasa, S.L., Madrid, ES / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K023676 is the FDA 510(k) clearance record for APPLANATION TONOMETER, a class II device, cleared for Optilasa, S.L. on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list one 510(k) clearance for Optilasa, S.L. As of , FDA records show no recalls naming K023676.

Clearance record

Decision date
Received
(174 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Optilasa, S.L. 338 Arturo Soria St., Madrid, ES
510(k) summary
Statement
Third party review
No

Clearances, product code HKX

Trailing 12 months
1 clearance under product code HKX in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HKX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260