Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-153: ANSI / IESNA RP-27.1-2005, Recommended Practice for Photobiological Safety for Lamps and Lamp Systems - General Requirements. (Radiology)

Date of Standard: 2005.

Addresses of Standards Organizations:

American National Standards Institute (ANSI)

25 West 43rd Street

4th Floor

New York, NY 10036

Illuminating Engineering Society of North America (IESNA)

120 Wall Street

New York, NY 10005-`

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF COMPLIANCE (OC)

(2)	OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)

(3)	OFFICE OF DEVICE EVALUATION (ODE)

(4)	OFFICE OF COMMUNICATION EDUCATION AND RADIATION PROGRAM (OCER)

Devices Affected:

All devices and products that emit non-coherent (i.e., non-laser) optical radiation

Processes Affected:

510(k), IDE, PMA, PDP, HDE, Design Control Input

Type of Standard:

National, Horizontal

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§878.4810	Laser Assisted Lipolysis	Class 2	ORK
§878.4810	Laser, Benign Prostatic Hyperplasia	Class 2	OEL
§878.4810	Laser, Cellulite Appearance	Class 2	OYW
§878.4810	Laser, Dental, Soft Tissue	Class 2	NVK
§878.4810	Light Based Over The Counter Wrinkle Reduction	Class 2	OHS
§878.4810	Light Based Over-The-Counter Hair Removal	Class 2	OHT
§878.4810	Massager, Vacuum, Light Induced Heating	Class 2	NUV
§878.4810	Neurosurgical Laser With Mr Thermography	Class 2	ONO
§878.4810	Over-The-Counter Powered Light Based Laser For Acne	Class 2	OLP
§878.4810	Powered Laser Surgical Instrument	Class 2	GEX
§878.4810	Powered Laser Surgical Instrument With Microbeam\Fractional Output	Class 2	ONG
§878.4810	Powered Light Based Non-Laser Surgical Instrument	Class 2	ONE
§878.4810	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	Class 2	ONF