Chrysalis Intelligence · Sponsors · Sight Sciences, Inc.

Sight Sciences, Inc.

Menlo Park, CA, US · 9 510(k) clearances · 1 recalls

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Total clearances

9

2020-08-11 → 2026-08-18

Last 12 months

3

Product codes

2

Most recent

2026-08-18

Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code	Device name	Class	Specialty	Clearances	Most recent
ORZ	Eyelid Thermal Pulsation System	Class II	Ophthalmic	5	2026-08-18
MRH	Pump, Infusion, Ophthalmic	Class II	General Hospital	4	2026-08-04

Safety

Recalls (1)

Class I (serious)

0

Risk of injury / death

Total recalls

1

Currently ongoing

1

Most recent

2022-03-23

Date	Severity	Status	Recall #	Product	Code	Reason
2022-03-23	Class II	Ongoing	Z-1001-2022	TearCare version 1.0 SmartHubs	—	Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance charact…

Filings

All 510(k) clearances (9)

Date	K-number	Device	Code	Class	Specialty
2026-08-18	K262479	TearCare System	ORZ	Class II	Ophthalmic
2026-08-04	K253760	OMNI Ultra Surgical System (1-110)	MRH	Class II	General Hospital
2026-04-27	K252409	TearCare MGX System	ORZ	Class II	Ophthalmic
2025-04-15	K242786	TearCare MGX System	ORZ	Class II	Ophthalmic
2023-12-27	K231084	TearCare MGX System	ORZ	Class II	Ophthalmic
2023-08-25	K232214	OMNI Surgical System	MRH	Class II	General Hospital
2021-12-21	K213045	TearCare System	ORZ	Class II	Ophthalmic
2021-03-01	K202678	OMNI Surgical System	MRH	Class II	General Hospital
2020-08-11	K201953	OMNI PLUS Surgical System	MRH	Class II	General Hospital