Recognition List Number: 027 Publication Date: 08/02/2011
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-65: ISO 15752 Second edition 2010-01-15, Ophthalmic instruments - Endoilluminators - Fundamental requirements and test for optical radiation safety. (Ophthalmic)
Date of Standard: 2010. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) |
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| Devices Affected: |
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| Processes Affected: |
| PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §874.4350 |
Source, Carrier, Fiberoptic Light |
Class 1 |
EQH |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §876.1500 |
Endoilluminator |
Class 2 |
MPA |
| §876.1500 |
Endoilluminator, Reprocessed |
Class 2 |
NKZ |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.4150 |
Instrument, Vitreous Aspiration And Cutting, Ac-Powered |
Class 2 |
HQE |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Dexiu Shi |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2246 |
| Silver Spring MD 20993 |
| 301/796-6860 |
| Email: dexiu.shi@fda.hhs.gov |
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