LUMENIS SELECTA DUET

K021550 · Ellex Medical Pty, Ltd. · GEX · Aug 9, 2002 · General, Plastic Surgery

Device Facts

• Record ID: K021550
• Device Name: LUMENIS SELECTA DUET
• Applicant: Ellex Medical Pty, Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

CAPSULOTOMY POSTERIOR IRIDOTOMY / IRIDECTOMY POSTERIOR MEMBRANECTOMY SELECTIVE LASER TRABELULOPLASTY (SLT)

Device Story

Lumenis Selecta Duet is a laser surgical instrument used by ophthalmologists in clinical settings. Device delivers laser energy to ocular tissues to perform capsulotomy, iridotomy/iridectomy, membranectomy, and selective laser trabeculoplasty (SLT). System functions as a surgical tool for precise tissue disruption or treatment within the eye. Physician operates device to target specific ocular structures; output is controlled laser energy. Benefits include minimally invasive treatment of ocular conditions like cataracts or glaucoma.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Laser surgical instrument; Class II; Product Code GEX. Operates as a laser system for ophthalmic surgery. Specific materials, energy parameters, and software details not disclosed in provided documentation.

Indications for Use

Indicated for patients requiring capsulotomy, posterior iridotomy/iridectomy, posterior membranectomy, or selective laser trabeculoplasty (SLT).

Regulatory Classification

Identification

(1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 0 9 2002

Mr. Kevin Howard Regulatory Officer Ellex Medical Pty. Ltd. 82 Gilbert Street Adelaide SA 5000 Australia

Re: K021550

Trade/Device Name: Lumenis Selecta Duet Regulation Number: 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: May 10, 2002

Received: May 13, 2002

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. 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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Milberson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ | _ O 2 | S

Device Name: LUMENIS DUET SELECTA

Indications For Use:

CAPSULOTOMY POSTERIOR IRIDOTOMY / IRIDECTOMY POSTERIOR MEMBRANECTOMY SELECTIVE LASER TRABELULOPLASTY (SLT)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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for

(Division Sign-Off)

Division of General, Restorative and Neurological Devices

| 510(k) Number | K021550 |
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Prescription Use Per 21 CFR 801.109) OR

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)