510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K213045Substantially Equivalent

TearCare System

Sight Sciences, Inc., Menlo Park CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K213045 is the FDA 510(k) clearance record for TearCare System, a class II device, cleared for Sight Sciences, Inc. on under FDA product code ORZ (Eyelid Thermal Pulsation System). FDA's definition for product code ORZ reads: "Therapeutic application of heat and massage to the eyelids". FDA records list 12 510(k) clearances for Sight Sciences, Inc., from to . As of , FDA records show no recalls naming K213045.

Clearance record

Decision date
Received
(90 days to decision)
Product code
ORZ Eyelid Thermal Pulsation System
Regulation
21 CFR 886.5200
Device class
Class II
Review panel
Ophthalmic
Applicant
Sight Sciences, Inc. 4040 Campbell Ave. Suite 100, Menlo Park CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ORZ

Trailing 12 months
2 clearances under product code ORZ in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code ORZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260