Cleared Traditional

K002510 - SMARTLENS

K002510 is an FDA 510(k) clearance for SMARTLENS, manufactured by Odc Ophthalmic Development Co. AG. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K002510 · Odc Ophthalmic Development Co. AG · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2000
Decision
64d
Days
Class 2
Risk

K002510 is an FDA 510(k) clearance for the SMARTLENS. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Odc Ophthalmic Development Co. AG (Lakewood, US). The FDA issued a Cleared decision on October 18, 2000 after a review of 64 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1930 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Odc Ophthalmic Development Co. AG devices

FDA 510(k) Submission Details - K002510

510(k) Number K002510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date October 18, 2000
Days to Decision 64 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 110d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKX Device Classification - Class 2, Special Controls

Product Code HKX Tonometer, Ac-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1930
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HKX Tonometer, Ac-powered

All 34
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K002510.
TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH)
K042099 · Retinapharma Technologies, Inc. · Dec 2004
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000
LEICA AT550
K990869 · Leica Microsystems, Inc. · Jun 1999
KEELER PULSAIR 3000 NON CONTACT TONOMETER
K990257 · Keeler Instruments, Inc. · Mar 1999
CANON TX-10 TONOMETER
K963079 · Canon USA, Inc. · Mar 1997