ELLEX 2RT

K122202 · Ellex Medical Pty, Ltd. · HQF · Jul 1, 2013 · Ophthalmic

Device Facts

• Record ID: K122202
• Device Name: ELLEX 2RT
• Applicant: Ellex Medical Pty, Ltd.
• Product Code: HQF · Ophthalmic
• Decision Date: Jul 1, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.4390
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of; Clinically Significant Macular Edema (CSME) .

Device Story

The 2RT (LR1532) is an ophthalmic laser system used by trained physicians in clinical settings to treat Clinically Significant Macular Edema (CSME). The device delivers focal laser energy to the Retinal Pigmented Epithelium (RPE) of the eye. By producing a controlled wound to the RPE, the laser treatment aims to address the underlying pathology of CSME. The physician operates the system to target specific areas of the retina, utilizing the laser's output to induce the intended therapeutic effect. The device serves as a tool for retinal intervention, with the clinical outcome dependent on the physician's precise application of the laser energy to the target tissue.

Technological Characteristics

Ophthalmic laser system (Class II, 21 CFR 886.4390, Product Code HQF). Designed for focal laser treatment of the Retinal Pigmented Epithelium.

Indications for Use

Indicated for patients with Clinically Significant Macular Edema (CSME) requiring focal laser treatment to the Retinal Pigmented Epithelium (RPE). For use by trained ophthalmic physicians.

Regulatory Classification

Identification

An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.

Submission Summary (Full Text)

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July 1, 2013

Ellex Medical Pty. Ltd. % Mr. Kevin Howard Senior Regulatory Officer 82 Gilbert Street Adelaide, South Australia 5000 Australia

Re: K122202

Trade/Device Name: Ellex 2RT Regulation Number: 21 CFR 886.4390 Regulation Name: Ophthalmic Laser Regulatory Class: Class II Product Code: HQF Dated: June 17, 2013 Received: June 19, 2013

Dear Mr. Howard:

· We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. or to devices 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 the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

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Page 2 - Mr. Kevin Howard

You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

**Deborah Falls -S**

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K122202

Device Name: 2RT (model number LR1532) ophthalmic laser system

Indications For Use:

The 2RT (LR1532) is indicated for use by a trained ophthalmic physician to produce a wound to the Retinal Pigmented Epithelium (RPE) of the retina of the eye, via focal laser treatment, in the treatment of;

Clinically Significant Macular Edema (CSME) .

Prescription Use × (part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

## Ka N. To --2013.06.25 11:59:05 -04'00'

(Division Sign-Off) Division of Ophthalmic and Ear, Nose, and Throat Devices 510(k) Number:_ K122202

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