FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Easy-Load Lens Delivery System
K Number: K161012
·
Decision Jul 6, 2016
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
62
Applicant Total
1
Review Days
86
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Basic Information
- Device Name
- Easy-Load Lens Delivery System
- K Number
- K161012
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 886.4300
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bausch and Lomb, Inc.,
- Date Received
- April 11, 2016
- Decision Date
- July 6, 2016
- 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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