Recognized Consensus Standards

Recognition List Number: 024 Publication Date: 06/10/2010

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 12-208: IEC 60601-2-22 Third Edition 2007-05, Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. (Radiology)

Date of Standard: 2007.

Address of Standards Organization:

International Electrotechnical Commission (IEC)

3, Rue de Varembe'

PO Box 131

CH-1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH (OIR)

Devices Affected:

Applies to laser equipment for medical applications, classified as a class 3B or a class 4 laser product according to the classification in IEC 60825-1.

Processes Affected:

51(k), PMA, IDE, Initial reports

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard and any annexes.

Transition:
FDA recognition of Edition 2.0:1995 of IEC 60601-2-22 is hereby superseded by recognition of IEC 60601-2-22 Third Edition 2007-05 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment. FDA will accept declarations of conformity, in support of premarket submissions, to IEC 60601-2-22:1995 Edition 2.0 until June 30, 2013. After this transition period, declarations of conformity to Edition 2.0:1995 of the standard will not be accepted.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
Unclassified	Device, Angioplasty, Laser, Coronary	Class 3	LPC
Unclassified	Device. Laser Peripheral Angioplasty	Class 3	LWX
Unclassified	Excimer Laser System	Class 3	LZS
Unclassified	Laser For Gastro-Urology Use	Class U	LNK
Unclassified	Laser, Dental	Class U	LYB
Unclassified	Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary	Class 3	LOI
Unclassified	Laser, Neurosurgical	Class 3	LKW
Unclassified	Laser, Neurosurgical, Argon	Class 3	LLF
Unclassified	System, Laser, Fiber Optic, Photodynamic Therapy	Class 3	MVG
Unclassified	System, Laser, Photodynamic Therapy	Class 3	MVF
Unclassified	System, Laser, Transmyocardial Revascularization	Class 3	MNO


Regulation Number	Device Name	Device Class	Product Code
§874.4500	Laser, Ent Microsurgical Carbon-Dioxide	Class 2	EWG
§874.4500	Laser, Neodymium:Yag, Pulmonary Surgery	Class 2	LLO

Regulation Number	Device Name	Device Class	Product Code
§878.4810	Powered Laser Surgical Instrument	Class 2	GEX

Regulation Number	Device Name	Device Class	Product Code
§884.4550	Laser, Neodymium:Yag For Gynecologic Use	Class 2	LLW
§884.4550	Laser, Surgical, Gynecologic	Class 2	HHR

Regulation Number	Device Name	Device Class	Product Code
§886.4390	Laser, Ophthalmic	Class 2	HQF

Regulation Number	Device Name	Device Class	Product Code
§886.4392	Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla	Class 2	LXS

Regulation Number	Device Name	Device Class	Product Code
§886.4670	Laser,System,Phacolysis	Class 2	MXO

Regulation Number	Device Name	Device Class	Product Code
§886.4690	Photocoagulator And Accessories	Class 2	HQB