FDA applicant
Alden Optical Labs., Inc.
FDA records 11 decisions for Alden Optical Labs., Inc. (Grand Junction, CO) from 1984 to 2013: 10 510(k) clearances and 1 original PMA approval. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 7 predicates, 2 of them its own earlier devices. 11 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Alden Optical Labs., Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2013
2026 so far, outlined.
Recalls per year
11in 2017
Class I Class II/III not classified
Planning a device like Alden Optical Labs., Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Alden”
FDA records each applicant name separately; these may or may not be the same firm.