FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MicroSTAAR Injector System Cartridges
K Number: K152357
·
Decision Oct 30, 2015
Classifications
1
FEI Numbers
38
Registration Numbers
38
Same Product Code
38
Applicant Total
2
Review Days
71
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Basic Information
- Device Name
- MicroSTAAR Injector System Cartridges
- K Number
- K152357
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- STAAR Surgical Company
- Date Received
- August 20, 2015
- Decision Date
- October 30, 2015
- Product Code
- KYB
- Advisory Committee
- Ophthalmic
- 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 |
|---|---|---|---|
| KYB | Lens, Guide, Intraocular | FDA class 1 | Ophthalmic |
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Other Clearances by STAAR Surgical Company
| K Number | Device Name | ||
|---|---|---|---|
| K172375 | MicroSTAAR Injector System Cartridges | Sep 6, 2017 | Substantially Equivalent |