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510(k) K843095

TRIA LENS SET by Optek Medico Co., Ltd. — Product Code HPC

K843095 is an FDA 510(k) premarket notification submitted by Optek Medico Co., Ltd. for the device "TRIA LENS SET". The FDA issued a decision of Substantially Equivalent on October 5, 1984. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Optek Medico Co., Ltd. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1984
Date Received
August 7, 1984
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 Optek Medico Co., Ltd.

  • K863048 — OPM SLIT LAMP MODEL P-1 & MODEL P-3 (September 3, 1986)
  • K861854 — OPM SLIT LAMP MODEL P-1 (July 11, 1986)

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)
  • K934859 — CONTACT LENSES (December 21, 1993)
  • 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)

FDA data resources