UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES

K991659 · Medart Corp. · GEX · Jul 29, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K991659
• Device Name: UNI-LASER 425P DIODE LASER SYSTEM & ACCESSORIES
• Applicant: Medart Corp.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 29, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of 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 Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions 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

Uni-Laser 425P is a diode laser system designed for soft tissue surgical applications. It functions by delivering laser energy to perform incision, excision, ablation, and coagulation (hemostasis). The device is intended for use by trained clinicians across multiple surgical specialties, including dermatology, dentistry, and general surgery. The laser energy interacts with target tissues (skin, muscle, mucosa, etc.) to achieve the desired surgical effect. The system is operated in clinical settings; the clinician directs the laser output to the target site to manage tissue during procedures. The device provides a surgical tool for precise tissue management, potentially reducing bleeding and improving procedural outcomes compared to traditional mechanical methods.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Diode laser system; intended for soft tissue incision, excision, ablation, and coagulation. Operates as a surgical laser. No specific materials, software, or connectivity details provided.

Indications for Use

Indicated for incision, excision, ablation, and coagulation of soft tissue across various surgical specialties including dermatology, plastic surgery, dentistry, ENT, neurosurgery, ophthalmology, pulmonary/thoracic, GI, urology, gynecology, orthopedics, podiatry, and general surgery. Specific applications include vascular lesion photocoagulation, blood vessel photothermolysis, pigmented lesion removal, and sulcular debridement.

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 29 1999

Marilyn M. Chou, Ph.D. Regulatory Consultant MedArt Corporation 11772 Sorrento Valley Road Suite 240 San Diego, California 92121

Re: K991659

> Trade Name: Uni-Laser 425P™ Diode Laser System and Accessories Regulatory Class: II Product Code: GEX Dated: May 13, 1999 Received: May 14, 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 : K 991659

Uni-laser 425P™ Diode Laser System Device Name:

## Indications For Use:

The Uni-laser 425P Diode Laser System and accessories are indicated for incision/excision, ablation, and coagulation (homeostasis) of 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 Photothermolysis of blood vessels (treatment of facial and leg veins) Removal of pigmented lesions

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)

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Division of General Restorative Devices K 991659
510(k) Number

Prescription Use _ (21 CFR 801.109)

OR

Over-The-Counter Use