DUAL YELLOW LASER, MODEL DUAL YELLOW D10B

K032397 · Norseld Pty., Ltd. · GEX · May 27, 2004 · General, Plastic Surgery

Device Facts

• Record ID: K032397
• Device Name: DUAL YELLOW LASER, MODEL DUAL YELLOW D10B
• Applicant: Norseld Pty., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: May 27, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to: Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars. Striea, and Psoriasis. Podiatry - for benign cutaneous lesions and warts. The Dual Yellow lase, operating at 511 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutancous pigmented lesions including but not limited to: Lentigines, Solar keratoses. Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhocic keratoses Verrucae vulgaris, and Warts.

Device Story

Copper bromide laser system; emits energy at 511 nm and 578 nm wavelengths. Device comprises cabinet, fiber optic delivery system, and user/software interface. Operated by clinicians in dermatology, plastic surgery, general surgery, or podiatry settings. Laser energy targets specific cutaneous lesions; 578 nm wavelength used for vascular lesions and inflammatory acne; 511 nm wavelength used for pigmented lesions. Clinical benefit includes removal or treatment of benign skin lesions and vascular conditions. Output controlled via software interface to manage laser parameters.

Clinical Evidence

Clinical evidence includes published literature supporting the 511 nm wavelength for pigmented lesions and a published clinical study supporting the 578 nm wavelength for the treatment of inflammatory acne vulgaris. Equivalence for other indications is based on comparison to legally marketed predicate devices.

Technological Characteristics

Copper bromide laser; dual wavelength output at 511 nm and 578 nm. System includes cabinet, fiber optic delivery system, and software-controlled user interface. Class II medical device (21 CFR 878.4810).

Indications for Use

Indicated for patients requiring treatment of benign cutaneous vascular lesions (e.g., telangiectasia, rosacea, angiomas, port wine stains, hemangiomas, acne vulgaris, psoriasis, scars, striae, warts) and benign cutaneous pigmented lesions (e.g., lentigines, keratoses, skin tags, naevi, syringomas). Used in dermatology, plastic surgery, general surgery, and podiatry.

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.

Predicate Devices

• ICN (and SLS BIOPHILE) NLite Laser Systems (K000811, K020729, K013488, K014130)
• Candela Vbeam (K021180)
• Norseld Dual Yellow Laser (K023899)
• Asclepion-Meditec YelloStar (K013940)
• COSMOS COMPACT KTP (K983020)
• Dio-Light/DioLite (K981447, K980201, K964074)
• Laserscope Lyra (K990903)
• Viridis Laser (K001784)

Submission Summary (Full Text)

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## MAY 27 2004

#### SECTION 9

510(k) SUMMARY

# KO32597

This 510(k) summary of safety and effectiveness for Norseld Dual Yellow D10B laser is submitted in accordance with the requirements of SMDA 1990 and follows Office of Device Evaluation guidance concerning the organization and content of a 510(k) summary.

- Applicant: Norseld Pty., Ltd.
:

- 9 Claxton St Address: Adelaide South Australia 5000
- Manufacturer: Norseld Pty, Ltd. 9 Claxton St Adelaide South Australia 5000
- Contact Person: Mr. Peter Davis Managing Director
- Telephone Number: 011-8-8231 9000 Fax Number: 011-8-8231 9009

Preparation Date: January 2004 (of the Summary)

Dual Yellow Laser, Dual Yellow D10B Laser Device Name:

Common Name: Laser surgical device

Classification: Laser surgical device Class II medical device 21 CFR 878.4810

> Product Code: GEX Panel: 79

Predicate devices: ICN (and SLS BIOPHILE) NLite Laser Systems (K000811, K020729, K013461, K014130); Candela Vbeam (K021180), and Norseld Dual Yellow Laser (K023899); Asclepion-Meditec YelloStar(K013940); COSMOS COMPACT KTP (K983020); Dio-Light/DioLite (K981447, K980201, K964074); Laserscope Lyra (K990903); and Viridis Laser (K001784).

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K032397 Page 2 of 3

- Device description: The Norseld Dual Yellow D10B Laser is a copper bromide laser which emits it energy at 511 and 578 nm. The device consists of an cabinet, fiber optic delivery system, and a user/software interface.
The Dual Yellow laser is indicated for the treatment of benign pigmented Indications: and cutaneous vascular lesions.

> The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutaneous vascular lesions including but not limited to:

Treatment of wrinkles. Periocular wrinkles, Periorbital wrinkles. Facial and leg telangiectasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars. Strica, and Psoriasis.

Podiatry - for benign cutaneous lesions and warts.

The Dual Yellow lase, operating at 511 nm, is indicated in dermatology, plastic surgery, and general surgery for treatment of benign cutancous pigmented lesions including but not limited to:

Lentigines, Solar keratoses. Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhocic keratoses Verrucae vulgaris, and Warts.

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K032397 Page 3 of 3

Supporting literature and articles were provided in support of the Performance Data: indications for use of the 511 nm wavelength.

> The results of a published clinical study were submitted in support of the indication for the treatment of inflammatory acne vulgaris using the 578 nm wavelength. Indications for the 578 nm wavelength were based on equivalency to cited legally marketed products.

- Based on the information in the notification Norseld Pty., Ltd. believes CONCLUSION: that Dual Yellow D10B Laser is substantially equivalent to the cited legally marketed predicates for the indications listed above..
rev. 2/2004

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the HHS logo in the center. The HHS logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the perimeter of the circle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 7 2004

Norseld Pty., Ltd. c/o Mr. Roger Barnes 342 Sunset Bay Road Hot Springs, Arkansas 71913

Re: K032397 Trade/Device Name: Norseld Pty., Ltd. Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in gencral and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: February 24, 2004 Received: March 1, 2004

Dear Mr. Barnes:

We have reviewed your Scction 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 enclosurc) 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, listing 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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#### Page 2 - Mr. Roger Barnes

This letter will allow you to begin marketing your device as described in your Section 510(k) rmarket 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrh/dsma/dsmamain.html

Sincercly vours.

Mark A Millburn

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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#### SECTION 7

### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): __K032397___________________________________________________________________________________________________________________________________________

Device Name: Norseld Pty., Ltd. Dual Yellow (Dual Yellow D10B Laser)

Indications for Use Statement:

The Dual Yellow laser, operating at 578 nm, is indicated in dermatology, plastic surgery, The Daar Fenrery for treatment of benign cutaneous vascular lesions including but not limited to:

Treatment of wrinkles, Periocular wrinkles, Periorbital wrinkles. Facial and leg telangicctasia, Rosacea, Cherry angiomas, Port wine stains, Hemangiomas and venous lakes, Angioma, Spider angioma, and Poikiloderma of Civatte, Inflammatory Acne Vulgaris, Verrucae/Warts, Scars. Striea, and Psoriasis.

Podiatry - for benign cutaneous lesions and warts.

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

| Concurrence of CDRH, Office of Device Evaluation |
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| Prescription Use X<br>(Per 21 CFR 801.109) | OR Over The Counter Use _____ |
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| (Division Sign-Off)<br>Division of General, Restorative,<br>and Neurological Devices |
|--------------------------------------------------------------------------------------|
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| 510(k) Number | K032397 |
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|---------------|---------|

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Page 2 of 2

## INDICATIONS FOR USE (continued):

The Dual Yellow lase, operating at 511 nm, is indicated in dermatology, plastic surgery, The Duar Tenow last, opening of benign cutaneous pigmented lesions including but not limited to:

Lentigines, Solar keratoses, Adenoma serabaceum, Skin tabs, Trichoepitheliomas (benign lesions similar to skin tags) Naevi, Keratoses, Syringomas Seborrhoeic kcratoses Verrucac vulgaris, and Warts.

Mark A Mellums

rev. 2/2004

Division Division of General, Restorative, and Neurologica. Devices

**510(k) Number** K032347