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510(k) K934859

CONTACT LENSES by Arno Intl., Inc. — Product Code HPC

K934859 is an FDA 510(k) premarket notification submitted by Arno Intl., Inc. for the device "CONTACT LENSES". The FDA issued a decision of Substantially Equivalent on December 21, 1993. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Arno Intl., Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 1993
Date Received
October 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Lens, Trial, Ophthalmic
Device Class
Class I
Regulation Number
886.1405
Review Panel
OP
Submission Type

Other clearances by Arno Intl., Inc.

  • K934858 — FRAME SPECTACLE (December 8, 1993)

Other clearances for product code HPC

  • K945443 — BOBES LENS SET (July 19, 1995)
  • K951437 — OTI MODEL TLS-60 (April 11, 1995)
  • K930195 — OPHTHALMIC TRIAL LENSES (January 6, 1994)
  • K930446 — MARCO TRIAL SETS (July 6, 1993)
  • K924786 — BURTON TRIAL LENS SET (April 14, 1993)
  • K920571 — TRIAL LENS SET (May 7, 1992)
  • K900478 — WOODLYN FULL APERTURE TRIAL LENS SET (February 21, 1990)
  • K873907 — CONFIRMATION TESTS (December 29, 1987)
  • K852056 — ACC CROSS CYLINDERS (June 5, 1985)
  • K843095 — TRIA LENS SET (October 5, 1984)

FDA data resources