Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
FDA premarket approval P040029/S019 · decided 2021-02-08
Approval details
- PMA number
- P040029
- Supplement
- S019
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- 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
- 2021-01-14
- Decision date
- 2021-02-08
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Sterling, VA
- Statement
- Addition of manufacturing alternatives for the Euclid Systems Orthokeratology (oprifocon A) Toric Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Toric Contact Lenses for Overnight Wear.
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