510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K002510Substantially Equivalent

Smartlens

Odc Ophthalmic Development Co. AG, Lakewood CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002510 is the FDA 510(k) clearance record for SMARTLENS, a class II device, cleared for Odc Ophthalmic Development Co. AG on under FDA product code HKX (Tonometer, Ac-Powered). FDA records list one 510(k) clearance for Odc Ophthalmic Development Co. AG. As of , FDA records show no recalls naming K002510.

Clearance record

Decision date
Received
(64 days to decision)
Product code
HKX Tonometer, Ac-Powered
Regulation
21 CFR 886.1930
Device class
Class II
Review panel
Ophthalmic
Applicant
Odc Ophthalmic Development Co. AG 777 S. Wadsworth Blvd., Lakewood CO
510(k) summary
Summary
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