PMA P040029S009

Device: Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant: Euclid Vision Corporation
PMA number: P040029
Supplement: S009
Product code: NUU
Decision date: 2019-10-24
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: Approval for the addition of an alternate lens blank supplier, with a change to the contact angle specification, for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.

Current openFDA PMA Record#

Device: Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Applicant: Euclid Vision Corporation
PMA number: P040029
Supplement: S009
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2019-10-24
Decision code: APPR
Date received: 2019-06-26
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the addition of an alternate lens blank supplier, with a change to the contact angle specification, for the manufacture of the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear.