Cleared Traditional

K011199 - PROVIEW EYE PRESSURE MONITOR

K011199 is an FDA 510(k) clearance for PROVIEW EYE PRESSURE MONITOR, manufactured by Bausch & Lomb, Inc.. The device is a Class 2 Ophthalmic device with product code HKY cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K011199 · Bausch & Lomb, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
74d
Days
Class 2
Risk

K011199 is an FDA 510(k) clearance for the PROVIEW EYE PRESSURE MONITOR. Classified as Tonometer, Manual (product code HKY), Class II - Special Controls.

Submitted by Bausch & Lomb, Inc. (Rochester, US). The FDA issued a Cleared decision on July 2, 2001 after a review of 74 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.

FDA 510(k) Submission Details - K011199

510(k) Number K011199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2001
Decision Date July 02, 2001
Days to Decision 74 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 110d · This submission: 74d
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 51
Devices cleared under the same product code (HKY) and FDA review panel - the closest regulatory comparables to K011199.
EYESOPEN TONOMETER
K032769 · Eye-Deas, LLC · Sep 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · Luneau SA · Feb 2003
F 900
K022054 · C.S.O. S.R.L. · Aug 2002
C.S.O. TONOMETER
K992835 · Cso · Jun 2000
REICHERT CT200 CONTACT TONOMETER
K000288 · Reichert Ophthalmic Instruments, Div. Leica, Inc. · Mar 2000
FRESCO PHOSPHENE TONOMETER AND OR PHOSPHENE TONOMETER AND OR FPT AND OR EYELID TONOMETER
K991840 · Bernard B. Fresco · Mar 2000
K011199 · PROVIEW EYE PRESSURE MONITOR
Download PDF FDA Summary Bausch & Lomb, Inc.