Submission Details
| 510(k) Number | K183167 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 15, 2018 |
| Decision Date | February 12, 2019 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
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
Feb 2019
Decision
89d
Days
Class 2
Risk
About This 510(k) Submission
K183167 is an FDA 510(k) clearance for the 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, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Bausch & Lomb, Incorporated (Rodchester, US). The FDA issued a Cleared decision on February 12, 2019, 89 days after receiving the submission on November 15, 2018. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5916.
Device Classification
| Product Code | HQD — Lens, Contact (other Material) - Daily |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5916 |
Manufacturer
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