Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens— 510(k) K183167

Substantially Equivalent

Bausch & Lomb, Incorporated

FDA 510(k) clearance K183167 for Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens; Boston EO (enflufocon B) Rigid Gas Permeable Contact Lens; Boston XO (hexafocon A) Rigid Gas Permeable Contact Lens; Boston XO2 (hexafocon B) Rigid Gas Permeable Contact Lens, Substantially Equivalent on 2019-02-12. Applicant: Bausch & Lomb, Incorporated.

Clearance details

Applicant: Bausch & Lomb, Incorporated
Product code: Code HQD
Advisory panel: Ophthalmic
Date received: 2018-11-15
Decision date: 2019-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rochester, NY, US

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