ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES— 510(k) K091327

Substantially Equivalent

Alden Optical Labs., Inc.

FDA 510(k) clearance K091327 for ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES, Substantially Equivalent on 2010-06-25. Applicant: Alden Optical Labs., Inc..

Clearance details

Applicant
Alden Optical Labs., Inc.
Product code
Code LPL
Advisory panel
Ophthalmic
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Alden, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code LPL

product code LPL
Injury
988
Other
4
Total
992

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.