Submission Details
| 510(k) Number | K981561 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 01, 1998 |
| Decision Date | July 24, 1998 |
| Days to Decision | 84 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
LIQUID ENZYME ID 90133
Jul 1998
Decision
84d
Days
Class 2
Risk
About This 510(k) Submission
K981561 is an FDA 510(k) clearance for the LIQUID ENZYME ID 90133, a Accessories, Soft Lens Products (Class II — Special Controls, product code LPN), submitted by Alcon Laboratories (Fort Worth, US). The FDA issued a Cleared decision on July 24, 1998, 84 days after receiving the submission on May 1, 1998. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
Device Classification
| Product Code | LPN — Accessories, Soft Lens Products |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |
Manufacturer
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