PMA P170035S017

Device: Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S017
Product code: LPM
Decision date: 2022-06-01
Generic name: Lenses, soft contact, extended wear
Approval order statement: Implementation of a new power measurement method on the Spin-Blot System for Bausch + Lomb Ultra® (samfilcon A)Visibility Tinted Soft (hydrophilic) Contact Lenses for Presbyopia Vision Correction.

Current openFDA PMA Record#

Device: Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact Lens
Applicant: Bausch and Lomb, Inc.,
PMA number: P170035
Supplement: S017
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2022-06-01
Decision code: OK30
Date received: 2022-05-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new power measurement method on the Spin-Blot System for Bausch + Lomb Ultra® (samfilcon A)Visibility Tinted Soft (hydrophilic) Contact Lenses for Presbyopia Vision Correction.