FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
bioli lOL Delivery System
K Number: K200057
·
Decision Jun 4, 2020
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
62
Applicant Total
4
Review Days
143
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Basic Information
- Device Name
- bioli lOL Delivery System
- K Number
- K200057
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ast Products, Inc.
- Date Received
- January 13, 2020
- Decision Date
- June 4, 2020
- Product Code
- MSS
- 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 |
|---|---|---|---|
| MSS | Folders And Injectors, Intraocular Lens (Iol) | FDA class 1 | Ophthalmic |
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