Cleared Traditional

K180820 - Tono Vue Non-Contact Tonometer

K180820 is an FDA 510(k) clearance for Tono Vue Non-Contact Tonometer, manufactured by Crystalvue Medical Corporation. The device is a Class 2 Ophthalmic device with product code HKX cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K180820 · Crystalvue Medical Corporation · Ophthalmic device
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Dec 2018
Decision
260d
Days
Class 2
Risk

K180820 is an FDA 510(k) clearance for the Tono Vue Non-Contact Tonometer. Classified as Tonometer, Ac-powered (product code HKX), Class II - Special Controls.

Submitted by Crystalvue Medical Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on December 14, 2018 after a review of 260 days - an extended review 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: 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 Crystalvue Medical Corporation devices

FDA 510(k) Submission Details - K180820

510(k) Number K180820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2018
Decision Date December 14, 2018
Days to Decision 260 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
150d slower than avg
Panel avg: 110d · This submission: 260d
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 22
Devices cleared under the same product code (HKX) and FDA review panel - the closest regulatory comparables to K180820.
Intraocular Pressure Tonometer EASYTON
K190382 · Company Elamed · Dec 2019
MiiS Horus Scope DPT 100
K181260 · Medimaging Integrated Solution, Inc (Miis) · Jun 2019
Keeler TonoCare Tonometer
K181143 · Keeler Instruments, Inc. · Feb 2019
PULSAIR INTELLIPUFF, PULSAIR DESKTOP MODEL 2414-P-2001, 2417-P-2000
K093298 · Keeler Instruments, Inc. · Dec 2010
NON-CONTACT TONOMETER, MODEL NT-4000
K031733 · Nidek, Inc. · Dec 2003
MODEL 30 CLASSIC PNEUMATONOMETER
K002395 · Xomed, Inc. · Dec 2000