FDA 510(k) Applications for Medical Device Product Code: MUW (Lens, Contact (Orthokeratology))

FDA 510(k) Applications for Medical Device Product Code "MUW"
(Lens, Contact (Orthokeratology))

FDA 510(k) Number	Applicant	Device Name	Decision Date
K973697	AIRPERM, INC.	AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY	04/08/1998
K183200	C&E GP Specialist, Inc.	iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses	01/09/2019
K160859	CONTAMAC LTD.	OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)	07/13/2016
K010109	PARAGON VISION SCIENCES	FLUOROPERM 151-OK, PARAGON HDS 100-OK	02/28/2001
K000224	PARAGON VISION SCIENCES	FLUROPERM 60-OK, PARAGON HDS-OK	04/17/2000
K003933	POLYMER TECHNOLOGY	BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY	02/16/2001