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510(k) K945443

BOBES LENS SET by Bobes S.A. — Product Code HPC

K945443 is an FDA 510(k) premarket notification submitted by Bobes S.A. for the device "BOBES LENS SET". The FDA issued a decision of Substantially Equivalent on July 19, 1995. The device falls under product code HPC (Set, Lens, Trial, Ophthalmic), a Class I device regulated under 21 CFR 886.1405. Bobes S.A. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 1995
Date Received
November 7, 1994
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 Bobes S.A.

  • K945445 — BOBES SLIT LAMP (October 17, 1995)
  • K945446 — BOBES TONOMETER (June 20, 1995)

Other clearances for product code HPC

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

FDA data resources