Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens +3 more— 510(k) K183167
Substantially EquivalentBausch & Lomb, Incorporated
FDA 510(k) clearance K183167 for Boston ES (enflufocon A) Rigid Gas Permeable Contact Lens +3 more, Substantially Equivalent on 2019-02-12. Applicant: Bausch & Lomb, Incorporated. Device class: 2.
Clearance details
- Device name as filed
- 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
- Applicant
- Bausch & Lomb, Incorporated
- Product code
- Code HQD
- Device class
- Class 2
- Regulation
- 21 CFR 886.5916
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rochester, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.