Cleared Traditional

K023838 - LUNEAU STERILE TONOMETER SEPARATION PRISMS

K023838 is an FDA 510(k) clearance for LUNEAU STERILE TONOMETER SEPARATION PRISMS, manufactured by Luneau SA. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K023838 · Luneau SA · Ophthalmic device
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Feb 2003
Decision
94d
Days
Class 2
Risk

K023838 is an FDA 510(k) clearance for the LUNEAU STERILE TONOMETER SEPARATION PRISMS. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Luneau SA (Chartres Cedex, FR). The FDA issued a Cleared decision on February 20, 2003 after a review of 94 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Luneau SA devices

FDA 510(k) Submission Details - K023838

510(k) Number K023838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2002
Decision Date February 20, 2003
Days to Decision 94 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 110d · This submission: 94d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HKY Device Classification - Class 2, Special Controls

Product Code HKY Tonometer, Manual
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 - HKY Tonometer, Manual

All 41
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K023838.
ICARE TONOMETER TA01I
K063873 · Tiolat OY · May 2007
MODIFICATION TO: OCU-FILM TIP COVER
K070534 · Reichert, Inc. · Mar 2007
TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER
K053430 · Medtronic Xomed, Inc. · Mar 2006
PROVIEW EYE PRESSURE MONITOR
K011199 · Bausch & Lomb, Inc. · Jul 2001
C.S.O. TONOMETER
K992835 · Cso · Jun 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000