Bobes Lens Set

FDA 510(k) K945443 · Bobes S.A.

Substantially Equivalent

510(k) numberK945443

Submission

Device name
Bobes Lens Set
Applicant
Bobes S.A.
Madrid, ES
Received
November 7, 1994
Decision date
July 19, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HPC – Set, Lens, Trial, Ophthalmic
Device class
Class I (low risk)
Regulation
21 CFR 886.1405
Specialty
Ophthalmic

Other 510(k)s with product code HPC

510(k)DeviceApplicantDecision
K951437Oti Model TLS-60HPC · Traditional Oti Medical, LLC04/11/1995SE
K930195Ophthalmic Trial LensesHPC · Traditional Optimark Accessories and Instruments01/06/1994SE
K934859Contact LensesHPC · Traditional Arno Intl., Inc.12/21/1993SE
K930446Marco Trial SetsHPC · Traditional Marco Ophthalmic, Inc.07/06/1993SE
K924786Burton Trial Lens SetHPC · Traditional R.H. Burton Co.04/14/1993SE
K920571Trial Lens SetHPC · Traditional R.H. Burton Co.05/07/1992SE
K900478Woodlyn Full Aperture Trial Lens SetHPC · Traditional Woodlyn, Inc.02/21/1990SE
K873907Confirmation TestsHPC · Traditional Richmond Products, Inc.12/29/1987SE
K852056Acc Cross CylindersHPC · Traditional Ascon Medical Instruments, Ltd.06/05/1985SE
K843095Tria Lens SetHPC · Traditional Optek Medico Co., Ltd.10/05/1984SE

More from Optek Medico Co., Ltd.

510(k)DeviceDecision
K945445Bobes Slit LampHJO · Traditional 10/17/1995SE
K945446Bobes TonometerHKY · Traditional 06/20/1995SE

Questions and answers

When was Bobes Lens Set cleared by the FDA?

Bobes Lens Set (K945443) received a 510(k) decision of Substantially Equivalent on July 19, 1995, 254 days after the submission was received.

What is the product code of K945443?

The FDA product code is HPC – Set, Lens, Trial, Ophthalmic, a Class I (low risk) device regulated under 21 CFR 886.1405.