Sight Sciences, Inc.
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000008813 FEI 3010363671
Sight Sciences, Inc. is a medical device manufacturer based in the United States, with 38 devices listed in FDA GUDID, FDA 510(k) and EUDAMED (FDA Class II and I; EU Class IIa) and 1 FDA recall as of 12 Nov 2026.
- Devices
- 38
- Registrations
- EUDAMEDFDA
- FDA recalls
- 11 ongoing
Registry facts
- Registries
- FDA GUDID 23
- FDA 510(k) 13
- EUDAMED 2
- Device classes
- FDA Class II 30
- FDA Class I 6
- EU Class IIa 2
- Top EMDN categories
- FDA recalls
- Identifiers
- EUDAMED SRN US-MF-000008813
- FDA FEI 3010363671
- DUNS 962750381
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI, FDA recalls
What Sight Sciences, Inc. makes
Sight Sciences, Inc. manufactures single-use ophthalmic surgical instruments, including trabeculotomes, ophthalmic needles, soft-tissue manipulation forceps, and ophthalmic curettes. The company also produces eyelid heat therapy systems, comprising both applicators and control units designed for meibomian gland treatment. Additional offerings include systems for tear clearance assistance and smart eyelid management solutions.
The company’s devices are regulated under FDA classifications, with products falling into Class I and Class II categories. These devices are listed in the FDA’s 510(k) and UDI registries. Sight Sciences, Inc. is based in the United States.
Catalogue
Search and filter all 38 devicesCompany details
- EUDAMED SRN
- US-MF-000008813
- FDA FEI number
- 3010363671
- DUNS number
- 962750381
- EU VAT number
- NL8261.21.950.B01
- EUDAMED status
- Active
- EUDAMED registered name
- Sight Sciences, Inc.
- Registered address
- 4040 Campbell Ave, 94025, Menlo Park, United States
- Website
- www.sightsciences.com
- PRRC contact
- Kathleen Chester
FDA recalls
FDA recall records list 1 recall initiated by Sight Sciences, Inc., initiated on 2022-03-23. By recorded status: 1 ongoing. The reasons filed fall into these groups: performance or accuracy. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 1
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2022
- 23 Mar 2022 Z-1001-2022 Class II Ongoing Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
Full distribution text
- 23 Mar 2022 Z-1001-2022 Class II Ongoing Ophthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their performance characteristics were not evaluated by the FDA prior to distribution.
Frequently asked questions
How many devices does Sight Sciences, Inc. have in the registry?
The registry currently lists 38 devices for Sight Sciences, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Sight Sciences, Inc.'s devices?
Among its 38 most recently registered devices, Sight Sciences, Inc. has devices listed in EUDAMED (2 devices), FDA 510(k) (13 devices) and FDA GUDID (23 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Sight Sciences, Inc.'s devices fall under?
Among its 38 most recently registered devices, the classes recorded for Sight Sciences, Inc.'s devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Sight Sciences, Inc.?
FDA recall records list 1 recall initiated by Sight Sciences, Inc., the most recent initiated on 23 Mar 2022. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Sight Sciences, Inc. in the registry?
The most recently registered devices listed for Sight Sciences, Inc. include OMNI Ultra Surgical System FG 09981, OMNI Ultra Surgical System (1-110), TearCare System and OMNI Ultra Surgical System.