iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
FDA premarket approval P080004/S040 · decided 2021-05-07
Approval details
- PMA number
- P080004
- Supplement
- S040
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- iSert® Pre-loaded System, iSert Preloaded IOL System, IPURE Pre-loaded System, PreVue Pre-loaded System
- Generic name
- intraocular lens
- Applicant
- Hoya Surgical Optics, Inc.
- Date received
- 2021-04-12
- Decision date
- 2021-05-07
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- HQL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Chino Hills, CA
- Statement
- Removal of the ethylene oxide ink indicator on individual sterilization pouches of fully preloaded intraocular lens devices, and replacement with an ethylene oxide indicator sticker that will be attached to the sterilization tray during batch sterilization.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| HOYA IS INJECTOR SYSTEM (K081346) | Hoya Surgical Optics, Inc. | 2009-03-23 |