Cleared Traditional

K213045 - TearCare System (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence.

K213045 · Sight Sciences, Inc. · Ophthalmic device
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Dec 2021
Decision
90d
Days
Class 2
Risk

K213045 is an FDA 510(k) clearance for the TearCare System. Classified as Eyelid Thermal Pulsation System (product code ORZ), Class II - Special Controls.

Submitted by Sight Sciences, Inc. (Menlo Park, US). The FDA issued a Cleared decision on December 21, 2021 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5200 - 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 Sight Sciences, Inc. devices

Submission Details

510(k) Number K213045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 2021
Decision Date December 21, 2021
Days to Decision 90 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
20d faster than avg
Panel avg: 110d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ORZ Eyelid Thermal Pulsation System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5200
Definition Therapeutic Application Of Heat And Massage To The Eyelids.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT03588624 Completed Interventional Industry-sponsored

Study of the TearCare System in Dry Eye Disease

29
Patients (actual)
3
Sites
Treatment
Purpose
Open label
Masking
Condition studied Dry Eye
Study design Single group
Eligibility All sexes · 22 Years+ · Healthy volunteers accepted
Principal investigator Jaime C Dickerson, PhD
Sponsor Sight Sciences, Inc. (industry)
Started 2018-07-12 → Primary completion 2018-10-11 → Completed 2018-11-08
Primary outcome
Mean Change in Tear Break-Up Time (TBUT) at 1-month From Baseline
Secondary outcome
Mean Change in Ocular Surface Disease Index (OSDI) Score From Baseline to Month 1
View full study on ClinicalTrials.gov