FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Viscoelastic Injector
K Number: K143205
·
Decision Dec 5, 2014
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
18
Applicant Total
11
Review Days
28
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Basic Information
- Device Name
- Viscoelastic Injector
- K Number
- K143205
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5725
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sight Sciences, Inc.
- Date Received
- November 7, 2014
- Decision Date
- December 5, 2014
- Product Code
- MRH
- Advisory Committee
- General Hospital
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MRH | Pump, Infusion, Ophthalmic | FDA class 2 | General Hospital |
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| K232214 | OMNI Surgical System | Aug 25, 2023 | Substantially Equivalent |
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| K201953 | OMNI PLUS Surgical System | Aug 11, 2020 | Substantially Equivalent |
| K173332 | OMNI Surgical System | Dec 21, 2017 | Substantially Equivalent |
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| K132494 | VISCOELASTIC INJECTOR | Oct 22, 2013 | Substantially Equivalent |