Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
FDA premarket approval P040029/S016 · decided 2021-02-04
Approval details
- PMA number
- P040029
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Euclid Vision Corporation
- Date received
- 2020-08-12
- Decision date
- 2021-02-04
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- Approval for model name additions to the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.