MUW

Product Code: MUW

Products Classified as MUW

4358

Lens, Contact (orthokeratology)

Rigid Gas Permeable Contact Lens.

Total Product Life Cycle (TPLC) Devices

4358

Lens, Contact (orthokeratology)

Rigid Gas Permeable Contact Lens.

FDA Consensus Standards

• Lens, Contact (Orthokeratology) [37850]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37852]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37869]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [31258]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [38769]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37075]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [38809]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [33619]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [34448]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37081]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37077]: 21 CFR §886.5916 🔎
• Lens, Contact (Orthokeratology) [37868]: 21 CFR §886.5916 🔎

Pre-market Approvals for MUW

P870024

PAFLUFOCON D RIGID GAS PERMEABLE CONTACT LENSES

PARAGON VISION SCIENCES

Pre-market Notifications for MUW

K183200	ISee (roflufocon D, Roflufocon E) Daily Wear Orthokeratology Contact Lenses	C&E GP Specialist, Inc.
K160859	OPTIMUM GP OK Daily Wear Contact Lens (roflufocon D & E)	CONTAMAC LTD.
K010109	FLUOROPERM 151-OK, PARAGON HDS 100-OK	PARAGON VISION SCIENCES
K003933	BOSTON EQUALENS II (OPRIFOCON A) CONTACT LENS FOR ORTHOKERATOLGY	POLYMER TECHNOLOGY
K000224	FLUROPERM 60-OK, PARAGON HDS-OK	PARAGON VISION SCIENCES
K973697	AIRPERM (SIFLUFOCON A) RIGID GAS PERMEABLE OK CONTACT LENSES FOR DAILY WEAR ORTHOKERATOLOGY	AIRPERM, INC.

Maude Adverse Events

UNKNOWN RIGID GAS PERMEABLE CONTACT LENS	BAUSCH & LOMB	2012-10-31
BOSTON ORTHO-K (OPRIFOCON A) SHAPING LENS	BAUSCH + LOMB	2010-06-22
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS	BAUSCH & LOMB	2007-03-23
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS	BAUSCH & LOMB, INC.	2006-01-23
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS	BAUSCH & LOMB, INC.	2006-01-23
ORTHOKERATOLOGY LENS	UNK	2000-04-17
OK LENS ("NOT CONTACS")	MAX LUND O.D.	1999-10-05
OK LENS	UNK	1999-09-20
ORTHOKERATOLOGY LENS	UNK	1999-09-15