Voroscope(Tm)

FDA 510(k) K871735 · Australian Biomedical Corporation , Ltd.

Substantially Equivalent

510(k) numberK871735

Submission

Device name
Voroscope(Tm)
Applicant
Australian Biomedical Corporation , Ltd.
Australia, AU
Received
May 5, 1987
Decision date
June 3, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HLJ – Ophthalmoscope, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 886.1570
Specialty
Ophthalmic

Other 510(k)s with product code HLJ

510(k)DeviceApplicantDecision
K142486Heine Beta 200, Heine Beta 200 S, Heine K 180HLJ · Abbreviated Heine Optotechnik GmbH & Co. KG05/18/2015SE
K142837Heine Sigma 250 & Heine Sigma 250 M2HLJ · Abbreviated Heine Optotechnik GmbH & Co. KG01/29/2015SE
K131959Heine Mini 3000(R) OphthalmoscopeHLJ · Abbreviated Heine Optotechnik GmbH & Co. KG03/07/2014SE
K131961Heine Beta 200(R) OphthalmoscopeHLJ · Abbreviated Heine Optotechnik GmbH & Co. KG12/04/2013SE
K131719Ophthalmoscopes Diagnostic Instrument KitsHLJ · Traditional Medical Devices (Pvt) , Ltd.10/30/2013SE
K123587Heine Mini 3000 LED OphthalmoscopeHLJ · Abbreviated Heine Optotechnik GmbH & Co. KG03/22/2013SE
K093495Otoscope and Ophthalmoscope Diagnostic Instrument KitsHLJ · Traditional American Diagnostic Corp.11/19/2010SE
K070270Piccolight E50,PICCOLIGHT E56,EUROLIGHT E10, Eurolight E30, and Eurolight E36HLJ · Traditional Kirchner & Wilhelm GmbH + Co.Kg11/05/2007SE
K05259966 Vision Tech Ophthalmoscope, Models YZ6E, YZ6F, YZ6G, YZ11, YZ11C, YZ11D, YZ25AHLJ · Traditional Suzhou 66 Vision Tech Co., Ltd.11/07/2006SE
K061278Optyse OphthalmoscopeHLJ · Abbreviated Ophthalmos , Ltd.05/16/2006SE

More from Ophthalmos , Ltd.

510(k)DeviceDecision
K862457Lynx El Microscopy Tissue ProcessorIDZ · Traditional 07/16/1986SE
K851660Donway Lifting FrameFPP · Traditional 08/07/1985SE
K853114Rotalok Wrist Strap, Rotalok Skin RetractorGAD · Traditional 08/06/1985SE
K843522Donway SplintITH · Traditional 02/07/1985SE

Questions and answers

When was Voroscope(Tm) cleared by the FDA?

Voroscope(Tm) (K871735) received a 510(k) decision of Substantially Equivalent on June 3, 1987, 29 days after the submission was received.

What is the product code of K871735?

The FDA product code is HLJ – Ophthalmoscope, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 886.1570.