POLARIS DIODE LASER SYSTEM AND ACCESSORIES

K990914 · Xintec Corporation · GEX · Jul 30, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990914
• Device Name: POLARIS DIODE LASER SYSTEM AND ACCESSORIES
• Applicant: Xintec Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 30, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include: Dermatology and Plastic Surgery for Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only); Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

Device Story

Polaris Diode Laser System is a surgical laser device used for soft tissue management. It functions by delivering laser energy to perform incision, excision, ablation, and coagulation (hemostasis) of soft tissues. The device is intended for use by trained clinicians in surgical settings across multiple medical specialties, including dermatology, dentistry, and general surgery. The clinician operates the laser to target specific tissues, such as vascular lesions, pigmented lesions, or diseased periodontal tissue. The laser energy induces photocoagulation or photothermolysis, allowing for precise tissue removal or vessel treatment. By providing a controlled surgical tool, the device assists in achieving hemostasis and tissue ablation, potentially reducing bleeding and improving surgical outcomes compared to traditional methods.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Diode laser system for soft tissue surgery. Operates via laser energy delivery for photocoagulation and photothermolysis. System includes laser console and accessories. Technical specifications and specific materials are not detailed in the provided documentation.

Indications for Use

Indicated for incision, excision, ablation, and coagulation of soft tissue in patients requiring surgical intervention across various specialties including dermatology, plastic surgery, dentistry, ENT, neurosurgery, ophthalmology, pulmonary/thoracic, gastroenterology, urology, gynecology, orthopedics, podiatry, and general surgery.

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

JUL 30 1999

Marilyn M. Chou, Ph.D. Executive Vice President Convergent Laser Technologies 900 Alice Street Oakland, California 94607

Re: K990914 Trade Name: Polaris™ Diode Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: July 15, 1999 Received: July 16, 1999

Dear Dr. Chou:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Marilyn M. Chou, Ph.D.

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## 510(k) Number: #K990914

Polaris™ Diode Laser System Device Name:

## Indications For Use:

The Polaris Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of soft tissue. Soft tissue which may be encountered in surgical procedures include skin, subcutaneous tissue, striated and smooth muscle, mucus membrane, lymph vessels and nodes, organs and glands and specifically for the following indications. Specific surgical specialties include:

Dermatology and Plastic Surgery for

100 million and the state of the state of the states of the states of the states of the states of the states of the states of the states of the states of the states of the st

Photocoagulation of dermatological vascular lesions, including port wine stains, telangiectasia, angioma, spider nevi, and other benign vascular lesions. Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions Photothermolysis

Dentistry (soft tissue only), including sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and oral surgery; Ear Nose & Throat; Otorhinolaryngology; Neurosurgery (coagulation only);

Ophthalmology/Oculoplastic; Pulmonary/Thoracic Surgery; Gastroenterology; Urology; Gynecology; Orthopedics; Podiatry; and General Surgery.

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K990914 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use | |
|------------------|-----------------------------------------|----|----------------------|--|
| (21 CFR 801.109) | | | | |

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