CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A)— 510(k) K111267
Substantially EquivalentAbbconcise Optical Group, LLC
FDA 510(k) clearance K111267 for CONCISE, SILICONE HYDROGEL DAILY WEAR SOFT CONTACT LENS (EFROFILCON A), Substantially Equivalent on 2011-11-08. Applicant: Abbconcise Optical Group, LLC. Device class: 2.
Clearance details
- Applicant
- Abbconcise Optical Group, LLC
- Product code
- Product 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
- Grand Junction, CO, US
Recent devices under product code LPL
view all- K260311 — Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
- K253875 — OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens +2 more
- K262941 — Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
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.