PMA P990013S038

Device: NanoFLEX One Piece Collamer Intraocular Lens (CIOL)
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S038
Product code: HQL
Decision date: 2019-07-19
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).

Current openFDA PMA Record#

Device: NanoFLEX One Piece Collamer Intraocular Lens (CIOL)
Applicant: Starr Surgical Co.
PMA number: P990013
Supplement: S038
Product code: HQL
Generic name: intraocular lens
Decision date: 2019-07-19
Decision code: APPR
Date received: 2019-04-22
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to modify the labeling to include the lioli-24 IOL Delivery System to the current list of recommended delivery systems included in the Directions for Use (DFU) for the NanoFLEX® One-Piece Collamer Intraocular Lens (CIOL), Model CC4204A, and the sphere and toric Visian® ICL Implantable Collamer Lenses (MICL/TMICL).