ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS— 510(k) K982904
Substantially EquivalentLes Laboratoires Blanchard
FDA 510(k) clearance K982904 for ESSTECH MULTI ASPHERIC (MULTIFOCAL) (HIOXIFILCON B) SOFT (HYDROPHILIC) CONTACT LENS, Substantially Equivalent on 1998-09-01. Applicant: Les Laboratoires Blanchard. Device class: 2.
Clearance details
- Applicant
- Les Laboratoires Blanchard
- Product code
- Code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chicago, IL, US
Recent devices under product code LPL
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- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
More clearances from Les Laboratoires Blanchard
view allAdverse 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.