Recognized Consensus Standards

Recognition List Number: 019 Publication Date: 12/19/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-53: ISO 18369-1 First edition 2006-08-15, Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labeling specifications. (Ophthalmic)

Date of Standard: 2006.

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:

Contact lenses

Processes Affected:

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

Type of Standard:

Vertical, International

Extent of Recognition:

Complete standard and any annexes with the following exception:

The four lens groupings for hydrogel lenses may not apply to silicone hydrogel lenses.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§886.5916	Lens, Contact (Orthokeratology)	Class 2	MUW
§886.5916	Lens, Contact (Other Material) - Daily	Class 2	HQD
§886.5916	Lens, Contact, Orthokeratology, Overnight	Class 3	NUU
§886.5916	Lens,Contact(Rigid Gas Permeable)-Extended Wear	Class 3	MWL

Regulation Number	Device Name	Device Class	Product Code
§886.5925	Lens, Contact, (Disposable)	Class 2	MVN
§886.5925	Lens, Contact, For Color Vision Deficiency	Class 2	NCZ
§886.5925	Lens, Contact, For Reading Discomfort	Class 2	NIC
§886.5925	Lenses, Soft Contact, Daily Wear	Class 2	LPL
§886.5925	Lenses, Soft Contact, Extended Wear	Class 3	LPM
§886.5925	System,In-Office Tinting,Contact Lenses	Class 2	MZD