Ophthalmoscope, Ac-powered

Device Code: 4190

Product Code(s): HLI

Device Classification Information

• Device Type ID: 4190
• Device Name: Ophthalmoscope, Ac-powered
• Regulation Description: Ophthalmoscope.
• Regulation Medical Specialty: Ophthalmic
• Review Panel: Ophthalmic
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED); Contact Lenses And Retinal Devices Branch (CLRD)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 886.1570 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: HLI
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Program

Recognized Standards

• 10-70 ISO 10943 Third Edition 2011-08-15
  Ophthalmic Instruments - Indirect Ophthalmoscopes
• 10-72 ISO 15004-1 First Edition 2006-06-01
  Ophthalmic Instruments - Fundamental Requirements And Test Methods - Part 1: General Requirements Applicable To All Ophthalmic Instruments
• 10-102 ANSI Z80.36-2016
  American National Standard For Ophthalmics - Light Hazard Protection For Ophthalmic Instruments

Total Product Life Cycle

• Device Type ID: 4190
• Device: Ophthalmoscope, Ac-powered
• Product Code: HLI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Ophthalmoscope.
• CFR Regulation Number: 886.1570 [🔎]

Premarket Reviews
Manufacturer	Decision
AMICO DIAGNOSTIC INCORPORATED
	SUBSTANTIALLY EQUIVALENT	1
BIOPTIGEN, INC.
	SUBSTANTIALLY EQUIVALENT	1
CENTERVUE SPA
	SUBSTANTIALLY EQUIVALENT	1
OPTOMEDICAL TECHNOLOGIES GMBH
	SUBSTANTIALLY EQUIVALENT	1
OPTOVUE, INC.
	SUBSTANTIALLY EQUIVALENT	2
PROPPER MANUFACTURING CO.,INC.
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Optovue, Inc.	II	Oct-04-2017
2	Optovue, Inc.	II	Aug-14-2017

TPLC Last Update: 2019-04-02 20:44:27