Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-57: ANSI Z80.13-2007, American National Standard for Ophthalmics - Phakic Intraocular Lenses. (Ophthalmic)
Date of Standard: 2007. |
| Address of Standards Organization: |
| American National Standards Institute (ANSI) |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
| |
|
| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED) |
|
|
| Devices Affected: |
| Phakic Intraocular lenses (IOL) |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| National, Vertical |
| Extent of Recognition: |
Complete standard and any annexes, with the following modification to 8.2:
NOTE: In using this maximum endotoxin level, the uncertainty of the test method should be taken into account. |
|
| Related CFR Citations and Product Codes: |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| Unclassified |
Lens, Intraocular, Phakic |
Class 3 |
MTA |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Don Calogero |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2500 |
| Silver Spring MD 20993 |
| 301/796-6483 |
| Email: don.calogero@fda.hhs.gov |
|
|
