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510(k) K852056

ACC CROSS CYLINDERS by Ascon Medical Instruments, Ltd. — Product Code HPC

K852056 is an FDA 510(k) premarket notification submitted by Ascon Medical Instruments, Ltd. for the device "ACC CROSS CYLINDERS". The FDA issued a decision of Substantially Equivalent on June 5, 1985. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Ascon Medical Instruments, Ltd. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1985
Date Received
May 9, 1985
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 Ascon Medical Instruments, Ltd.

  • K852054 — CONTACT LENS LOUPE, INSPETION LOUPE (September 5, 1985)
  • K852055 — ASCON OPHTHALMIC SPONGE (September 4, 1985)
  • K852548 — ATL 225 MW TRAIL LENS SET (July 31, 1985)
  • K852057 — ASCON SURGICAL INSTRUMENTS (June 27, 1985)
  • K852126 — ATF 101 TRAIL FRAME (June 5, 1985)

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)
  • K843095 — TRIA LENS SET (October 5, 1984)

FDA data resources