Home / 510(k) Clearances / K940848

510(k) K940848

GELFLEX by Venture Management Corp. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 7, 1995
Date Received
February 23, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by Venture Management Corp.

  • K954972 — LYELL SOUND (January 24, 1996)
  • K943178 — DELTA (April 7, 1995)

Other clearances for product code LPL

  • K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with (May 29, 2026)
  • K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegav (May 21, 2026)
  • K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (May 19, 2026)
  • K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PU (April 29, 2026)
  • K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (March 19, 2026)
  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Bl (December 23, 2025)
  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 2025)