Recognition List Number: 019 Publication Date: 12/19/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 10-51: ISO 15004-2 First edition 2007-02-15, Ophthalmic Instruments - Fundamental requirements and test methods Part 2: Light hazard protection. (Ophthalmic)
Date of Standard: 2007. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
|
SWITZERLAND
|
|
| 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: |
| All ophthalmic instruments that direct optical radiation at or into the eye including but not limited to: Direct Opthalmoscopes, AC and DC Powered, Indirect, Opthalmoscopes, AC and DC Powerd, Slit Lamps, Fundus Cameras, Specular Microscopes, Endoilluminators, Operation Microscopes for ocular surgery. |
|
| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE, Design Control Input |
|
| Type of Standard: |
| International, Horizontal |
| Extent of Recognition: |
| Complete standard and any annexes. |
|
| Related CFR Citations and Product Codes: |
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 |
| §878.4700 |
Microscope, Operating & Accessories, Ac-Powered, Ophthalmic |
Class 1 |
HRM |
| §878.4700 |
Microscope, Operating, Non-Electric, Ophthalmic |
Class 1 |
HRB |
| §878.4700 |
Microscope, Surgical, General & Plastic Surgery |
Class 1 |
FSO |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1120 |
Camera, Ophthalmic, Ac-Powered |
Class 2 |
HKI |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1570 |
Ophthalmoscope, Ac-Powered |
Class 2 |
HLI |
| §886.1570 |
Ophthalmoscope, Battery-Powered |
Class 2 |
HLJ |
| §886.1570 |
Ophthalmoscope,Laser,Scanning |
Class 2 |
MYC |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1780 |
Retinoscope, Ac-Powered |
Class 2 |
HKL |
| §886.1780 |
Retinoscope, Battery-Powered |
Class 1 |
HKM |
| |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §886.1850 |
Biomicroscope, Slit-Lamp, Ac-Powered |
Class 2 |
HJO |
| §886.1850 |
Device,Analysis,Anterior Segment |
Class 2 |
MXK |
| §886.1850 |
Microscope, Specular |
Class 2 |
NQE |
| |
|
| Relevant Guidance: |
| There is no relevant guidance developed at this time. |
|
| FDA Technical Contact: |
| Sharon A. Miller |
| FDA/CDRH/OCER |
| 10903 New Hampshire Avenue Building 66, Room 4661 |
| Silver Spring MD 20993 |
| 301/796-2471 |
| Email: sharona.miller@fda.hhs.gov |
|
|
|
| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
|
|
