Submission Details
| 510(k) Number | K170007 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 03, 2017 |
| Decision Date | May 31, 2017 |
| Days to Decision | 148 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens
May 2017
Decision
148d
Days
Class 2
Risk
About This 510(k) Submission
K170007 is an FDA 510(k) clearance for the Acuity 58 (Enflufocon B) Rigid Gas Permeable Contact Lens, a Lens, Contact (other Material) - Daily (Class II — Special Controls, product code HQD), submitted by Acuity Polymers, Inc. (Rochester, US). The FDA issued a Cleared decision on May 31, 2017, 148 days after receiving the submission on January 3, 2017. 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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