HEINE Fa+4()15/822EMi:ifhnecm-wwhneorA

HEINE Optotechnik GmbH & Co. KG . Kientalstr 7 82211 Herrsching -Germany FEB 2 6 2013Tel. +49(0)81 52/38- 0 a 4()123-0 -al nb hiecm- Ien~o

51 0(k) Summary of Safety and Effectiveness

Submitter Information: HEINE Optotechnik GmbH & Co. KGKientalstr. 782211 HerrschingGermanyRegistration Number: 1000379039Owner/Operator Number: 9003020

Official Correspondent: Mr. Jbrg R6nnauDirector Regulatory AffairsHEINE Optotechnik GmbH & Co. KGPhone: +49 8152 38 0

US Agent (Contact): Benoit St. JeanHEINE USA, ltd.10 Innovation WayDover, NH 03820 USAPhone: + 1 603 7427217E-mail: Bstiean~ahheine-na.com

Date Prepared: September 3rd, 2012

Device(s) Identification:Device Trade Name: HEINE OMEGA®500Common Name: Indirect ophthalmoscope

Classification of the device:Device Classification Name: OphthalmoscopeProduct Code: HLI (AC) and HLJ (DC)Device Classification No.: Part 886.1570Panel: Ophthalmic Devices (86)Regulatory Status: Class 11

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Device Description:The HEINE OMEGA® 500 is an indirect ophthalmoscope, worn on the user's head to provideillumination and viewing optics in order to examine the media and the retina of a patient'seye. The ophthalmoscope can be operated either by rechargeable battery or directly bymains power supply.The HEINE OMEGA® 500 allows wireless comfortable movement for the user and mobilecharging (depending on chosen power source).

Intended Use:The indirect Ophthalmoscope HEINE OMEGA® 500 is an AC-powered or battery powereddevice for medical professionals, containing illumination and viewing optics intended toexamine the media (cornea, aqueous, lens, vitreous) and the retina of the eye.

Predicate devices:

Device Trade Name: Vantage Plus Binocular Indirect OphthalmoscopeApplicant: Keeler Instruments Inc.510 (k) No.: K060822

Device Trade Name: NEITZ Binocular Indirect Ophthalmoscope 10-AApplicant: NEITZ Instruments Company, Ltd.510 (k) No.: K942712

Device Trade Name: Model #1 2000 Binocular Indirect OphthalmoscopeApplicant: Welch Allyn, Inc.51 0(k) No.: K930023

The HEINE OMEGA 500 is considered substantial equivalent to the Vantage Plus BinocularIndirect Ophthalmoscope (K060822), NEITZ Binocular Indirect Ophthalmoscope 10-A(K942712) and Welch Allyn Model #1 2000 Binocular Indirect Ophthalmoscope (K930023).

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HEINELabeling on the products:

HEINE OMEGA 500

total view from behind operator's view

view from the left backside of the headband

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HEINAKeeler Vantage Plus

total view operators view

view from the left backside of the headband

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HEINANEITZ 10-a LED

total view operator's view

view from the left backside of the headband

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HEINE

Summary of Non-Clinical Performance Testing:The HEINE OMEGA® 500 indirect ophthalmoscope is tested according to the"Ophthalmoscope Guidance" in respect to optical radiation hazard with ophthalmoscopes(ISO 10943). Additionally testing in accordance with applicable requirements of ISO 15004-2"Ophthalmic instruments - Fundamental requirements and test methods" has beenperformed.

Conclusion:HEINE Optotechnik believes that the HEINE OMEGA®500 is substantially equivalent to thecurrently legally marketed devices. They do not introduce new indications for use, have thesame technological characteristics and do not introduce new potential hazards or safetyrisks.

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DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

7:1 February 2,2013 Food and Drug Administraion26,10903 New Hamrpshire AvenueDocument Control Center - W066-0609Silver Spring, MD 20993-0002

Heine Optotechnik GmbH- & Co. Kg.% Mr. Alexander SchapovalovTUV Sud America, Inc.1775 Old Highway 8 NWNew Brighton, MIN 55112-1891

Re: K123316Trade/Device Name: Heine Omega 500Regulation Number: 21 CER 886.1570Regulation Name: OphthalmoscopeRegulatory Class: Class 11Product Code: HLI, HLJDated: February 1, 2013Received: February 11, 2013

Dear Mr. Schapovalov:

We have reviewed your Section 51 0(k) premarket notification of intent to market the devicereferenced above and have determined the device is substantially equivalent (for the indicationsfor use stated in the enclosure) to legally marketed predicate devices marketed in interstatecommerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or todevices that have been reclassified in accordance with the provisions of the Federal Food, Drug,and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA).You may, therefore, market the device, subject to the general controls provisions of t he Act.

The general controls provisions of the Act include requirements for annual registration, listing ofdevices, good manufacturing practice, labeling, and prohibitions against misbranding andadulteration. Please note: CDRH does not evaluate information related to contract liabilitywarranties. We remind you; however, that device. labeling must be truthful and not misleading.

.If your device is classified (see above) into either class 11 (Special Controls) or class III (PMA),it may be subject to additional controls. Existing major regulations affecting your device can befound in the Code of Federal Regulations, Title 2 1, Parts 800 to 898. In addition, FDA maypublish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not meanthat FDA has made a determination that your device complies with other requirements of the Actor any Federal statutes and regulations administered by other Federal agencies. You mustcomply with all the Act's requirements, including, but not limited to: registration and listing (21

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medicaldevice-related adverse events) (21 CFR 803); good manufacturing practice requirements as setforth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronicproduct radiation control provisions (Sections 53 1-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), pleasego to htto)://www.fdasjzov/AboutFDA/CentersOffices/CDRH/CDRHOtfices/ucm 15809.htm forthe Center for Devices and Radiological Health's (CDRH4's) Office of Compliance. Also, pleasenote the regulation entitled, "Misbranding by reference to premarket notification" (2 1 CFR Part807.97). For questions regarding the reporting of adverse events under the MDR regulation (21CFR Part 803), please go tohttp://www.fda.2ov/MedicalDevices/Safety/RefortaProblem/default.htm for the CDRI-'s Officeof Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from theDivision of Small Manufacturers, International and Consumer Assistance at its toll-free number(800) 638-2041 or (301) 796-7100 or at its Internet addresshttp://www.fda.gov/Medicalflevices/ResourcesforYou/lndustry/default.htm.

Sincerely yours,

Kesia tM eAJae 17s

for Malvina B. Eydelman, M.D.DirectorDivision of Ophthalmic and Ear, Nose,

and Throat DevicesOffice of Device EvaluationCenter for Devices and Radiological Health

Enclosure

Indications for Use

51 0(k) number (if known):Device Name: HEINE OMEGA® 500Indications For Use:

The indirect ophthalmoscope HEINE OMEGA® 500 is an AC-powered or batterypowered device for medical professionals, containing illumination and viewing opticsintended to examine the media (cornea, aqueous, lens, vitreous) and the retina of theeye.

Prescription Use X AND/OR Over-The-Counter Use_____(part 21 .CFR 801 Subpart D) (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE ON ANOTHER PAGE IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kesia Y. Alexanderrr201 3.02.26hW V3 '00

(Division Sign-Off)Division of Ophthalmic and Ear, Nose,

and Throat Devices510(k) Number: K123316