FDA 510(k) Pathway — Class II Medical Device

The Complete
Tear Film Diagnostic

One device. Every parameter. 60 seconds.

TearScan is a tabletop diagnostic instrument that measures all critical tear film parameters in a single, automated test. No more juggling four devices. No more incomplete diagnoses.

6 Parameters Measured
60s Test Duration
1 Unified Device
TearScan Analysis
TearScan Diagnostic Unit
60-Second Test
AI Classification
50nL Sample
Clinical Report

The Problem

4 Devices. $60,000+. Still Incomplete.

Today's dry eye diagnosis is fragmented across multiple instruments, each measuring only a fraction of the tear film. Clinicians are forced to piece together an incomplete picture.

TearLab

$5,000 - $8,000
Osmolarity only. One parameter from one eye at a time.

OCULUS Keratograph 5M

$15,000 - $30,000
Meibography and NIBUT only. No osmolarity, no lipid layer quantification.

LipiView II

$5,000 - $10,000
Lipid layer imaging only. Cannot measure osmolarity or gland structure.

InflammaDry

$15 per test
MMP-9 inflammation marker only. No imaging, no quantification.

37M
Americans with dry eye disease
344M
People affected globally
80%
Estimated underdiagnosed
Tear Film Analysis

The Device

Tabletop Precision.
Automated Simplicity.

TearScan is a compact tabletop instrument roughly the size of a small desktop printer. With an integrated chinrest, display screen, and three measurement modules, it delivers a complete tear film profile without the patient ever leaving the chair.

  • Integrated chinrest and forehead rest for stable, repeatable positioning
  • Three co-aligned measurement modules: microfluidic, interferometric, and infrared imaging
  • Touchscreen display with real-time tear film visualization
  • Disposable microfluidic cartridge for tear sample osmolarity analysis
  • EMR integration via HL7 FHIR for seamless clinical workflow

Patient Workflow

Chin Down. Results Up.

Zero added chair time. A complete tear film diagnostic in four effortless steps.

1

Insert Cartridge

Load a single-use microfluidic cartridge into the device. Takes 2 seconds.

2

Patient Positions

Patient places chin on rest, just like a slit lamp exam. Familiar and comfortable.

3

Automated Scan

TearScan runs all six measurements automatically. No technician interaction needed during the test.

4

Clinical Report

Complete tear film profile with AI-powered DED classification delivered in 60 seconds.

What It Measures

Six Parameters. One Test.

Every clinically significant tear film metric, measured simultaneously from a single patient interaction.

Tear Osmolarity

Microfluidic Chip · 50nL Sample

Gold-standard biomarker for dry eye disease. TearScan's microfluidic sensor requires just 50 nanoliters of tear fluid collected via a disposable cartridge, measuring osmolarity with laboratory-grade accuracy at the point of care.

Lipid Layer Thickness

White-Light Interferometry

Quantifies the outermost protective lipid layer of the tear film. Thin or absent lipid layers are the hallmark of evaporative dry eye, the most common subtype. Measured non-invasively via spectral interferometry.

Meibomian Gland Structure

Infrared Meibography

Non-contact infrared imaging reveals the morphology of meibomian glands in both upper and lower eyelids. Detects gland dropout, truncation, and dilation that indicate meibomian gland dysfunction (MGD).

Non-Invasive TBUT

Videokeratography

Measures tear film stability by tracking the time to first break-up without fluorescein dye. Projected ring patterns on the cornea detect tear film disruption with sub-second precision, eliminating observer bias.

Tear Meniscus Height

Automated Imaging

Precisely measures the tear meniscus along the lower lid margin. Low meniscus height is an indicator of aqueous-deficient dry eye, helping differentiate between DED subtypes for targeted treatment.

AI DED Subtype Classification

Machine Learning Algorithm

Proprietary AI model integrates all six measurements to classify dry eye disease as evaporative, aqueous-deficient, or mixed. Provides a confidence-scored diagnosis aligned with the TFOS DEWS II framework, guiding personalized treatment.

Competitive Comparison

One Device to Replace Them All

No other instrument on the market delivers a complete tear film profile. TearScan is the first.

Parameter TearScan TearLab Keratograph 5M LipiView II InflammaDry
Tear Osmolarity × × ×
Lipid Layer Thickness × × ×
Meibomian Gland Imaging × × ×
Non-Invasive TBUT × × ×
Tear Meniscus Height × × ×
AI DED Classification × × × ×
MMP-9 Inflammation × × × ×
Device Cost $8K - $12K $5K - $8K $15K - $30K $5K - $10K N/A
Per-Test Cost $15 - $20 $4 - $6 $0 $0 $15

TearScan: 6 of 7 parameters. No other device exceeds 3.

The only all-in-one tear film diagnostic on the market.

For Clinicians

Built for Your Practice

Add comprehensive dry eye diagnostics without adding chair time, staff, or complexity.

Workflow Integration

TearScan slots into your existing exam flow. Patients are already in the chair. The test adds zero additional visit time.

  • Same slit lamp positioning patients already know
  • Automated test requires no technician oversight
  • HL7 FHIR integration pushes reports directly to your EMR
  • Compact footprint fits any exam room

Reimbursement

Dry eye testing is well-reimbursed. TearScan's multi-parameter output supports billing across multiple established CPT codes.

  • CPT 83861 — Tear osmolarity testing
  • CPT 92285 — External ocular photography
  • CPT 0507T — Tear film imaging (lipid layer)
  • Additional E/M codes for comprehensive evaluation

ROI

At 8-12 tests per day, TearScan pays for itself in 3-6 months. Ongoing consumable revenue is margin-positive from day one.

  • Device cost recovered in 3-6 months
  • Higher diagnostic capture rate per patient visit
  • Drives treatment revenue (Rx, IPL, LipiFlow referrals)
  • Replaces $30K-$60K in separate instrumentation

Clinical Science

Grounded in TFOS DEWS II

TearScan's diagnostic framework is built on the gold-standard Tear Film & Ocular Surface Society guidelines for dry eye disease classification.

Understanding DED Subtypes

Dry eye disease is not a single condition. The TFOS DEWS II report established that effective treatment requires identifying the specific subtype: is the tear film evaporating too quickly, or is the body not producing enough tears? Most patients present with a combination of both.

TearScan is the first point-of-care device that captures enough tear film data to classify DED subtype automatically, enabling targeted rather than empirical treatment.

Evaporative Dry Eye

Caused by meibomian gland dysfunction. Identified by thin lipid layer, short TBUT, and gland dropout on meibography. The most common subtype, affecting up to 86% of DED patients.

Aqueous-Deficient Dry Eye

Insufficient tear production from the lacrimal gland. Characterized by low meniscus height, elevated osmolarity, and intact lipid layer. Associated with autoimmune conditions such as Sjogren's syndrome.

Mixed-Mechanism Dry Eye

Features of both evaporative and aqueous-deficient disease. The most common clinical presentation. Requires multi-modal treatment targeting both lipid layer and aqueous volume.

Foundation Literature

  • Craig JP, et al. "TFOS DEWS II Definition and Classification Report." Ocul Surf. 2017;15(3):276-283.
  • Wolffsohn JS, et al. "TFOS DEWS II Diagnostic Methodology Report." Ocul Surf. 2017;15(3):539-574.
  • Bron AJ, et al. "TFOS DEWS II Pathophysiology Report." Ocul Surf. 2017;15(3):438-510.
  • Lemp MA, et al. "Tear osmolarity in the diagnosis and management of dry eye disease." Am J Ophthalmol. 2011;151(5):792-798.
  • Blackie CA, et al. "The relationship between dry eye symptoms and lipid layer thickness." Cornea. 2009;28(7):789-794.
  • Arita R, et al. "Noncontact infrared meibography to document age-related changes of the meibomian glands." Ophthalmology. 2008;115(5):911-915.
  • Stapleton F, et al. "TFOS DEWS II Epidemiology Report." Ocul Surf. 2017;15(3):334-365.

Clinical Validation Approach

Multi-center prospective study design comparing TearScan measurements against established predicate devices (TearLab, Keratograph 5M, LipiView II) in a cohort of DED patients and age-matched controls. Primary endpoints: measurement concordance, diagnostic sensitivity/specificity, and DED subtype classification accuracy versus expert panel consensus.

Regulatory & Trust

Built for Clinical Standards

TearScan is designed from the ground up to meet the regulatory, quality, and security requirements of clinical diagnostics.

FDA 510(k) Class II

Pursuing clearance via the 510(k) pathway with established predicate devices including TearLab osmolarity system and OCULUS Keratograph.

HIPAA Compliant

All patient data encrypted at rest (AES-256) and in transit (TLS 1.3). No cloud dependency for device operation. Optional secure EMR sync.

ISO 13485

Quality management system designed to ISO 13485 standards for medical devices. Full design history file, risk management per ISO 14971.

Clinical Validation

Multi-center prospective clinical study protocol with IRB oversight. Designed to demonstrate equivalence to predicate devices and superior diagnostic utility.

Pricing

All-in-One Economics

The cost of one TearLab plus one LipiView. The diagnostic capability of all four devices combined.

Consumable
$15 - $20
Per test cartridge
  • Single-use microfluidic cartridge
  • Pre-calibrated — no daily calibration needed
  • 12-month shelf life at room temperature
  • Individually sealed and lot-tracked
  • Volume pricing available for high-volume practices

Replace $35,000 - $60,000 in separate devices for under $12,000.

At 10 tests per day with standard reimbursement, the device pays for itself within 4 months.

Get Started

See TearScan in Action

Schedule a live demonstration to see TearScan's complete tear film analysis. We will walk you through the device, the clinical workflow, and the economics for your practice.

Union Group, Inc.

Request a Demo