GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS— 510(k) K962710
Substantially EquivalentGelflex Laboratories
FDA 510(k) clearance K962710 for GELFLEX DELTA 55 (METHAFILCON A) HYDROPHILIC CONTACT LENS, Substantially Equivalent on 1996-09-05. Applicant: Gelflex Laboratories. Device class: 2.
Clearance details
- Applicant
- Gelflex Laboratories
- 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
- Perth, Western, Wa, AU
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
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Gelflex Laboratories
view all- K181558 — Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens
- K030027 — GELFLEX SYNERGY SOFT LENS HIOXFILCON 49% WATER CONTENT CLEAR OR BLUE VISITINT; GELFLEX HIOXIFILCON SOFT CONTACT LENS 49%
- K962711 — GELFLEX ALPHA (POLYMACON) HYDROPHILIC CONTACT LENS
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.