PMA P040029S003

Device: EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
Applicant: Euclid Vision Corporation
PMA number: P040029
Supplement: S003
Product code: NUU
Decision date: 2016-05-26
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: Approval of name change from JSZ Orthokeratology (oprifilconA) Contact Lenses for Overnight Wear to Euclid System Orthokeratology (oprifilcon A) Contact Lenses for Overnight Wear.

Current openFDA PMA Record#

Device: EUCLID SYSTEMS ORTHOKERATOLOGY (OPRIFOCON A) CONTACT LENSES FOR OVERNIGHT WEAR
Applicant: Euclid Vision Corporation
PMA number: P040029
Supplement: S003
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2016-05-26
Decision code: APPR
Date received: 2016-01-29
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval of name change from JSZ Orthokeratology (oprifilconA) Contact Lenses for Overnight Wear to Euclid System Orthokeratology (oprifilcon A) Contact Lenses for Overnight Wear.