LASEMAR 800, 1000, 1500

K092860 · Eufoton S.R.L. · GEX · Jul 16, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K092860
• Device Name: LASEMAR 800, 1000, 1500
• Applicant: Eufoton S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jul 16, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for :surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracion who endoscopic equipment for medical Aesthetics including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery, Ophthalmology, Orthopedics, Podiator, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser Assisted Linolysis Assisted Lipolysis.

Device Story

Lasemar 800, 1000, 1500 are diode laser systems for soft tissue surgery. Device delivers laser energy via fiber delivery systems and accessories. Used by medical specialists in clinical settings (OR, clinic) for vaporization, incision, excision, cutting, hemostasis, and coagulation. Supports wide range of specialties including urology, plastic surgery, dermatology, and laser-assisted lipolysis. Physician operates laser console to control energy delivery to target tissue. Output provides thermal energy for tissue interaction; aids in surgical precision and hemostasis. Benefits include controlled tissue ablation and reduced bleeding during procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological characteristics and intended use compared to existing legally marketed laser surgical instruments.

Technological Characteristics

Diode laser system; wavelengths 800nm, 1000nm, 1500nm. Energy delivery via fiber optic systems. Class II surgical laser. Intended for soft tissue interaction. Standard electrical power source. Sterilization of accessories via standard methods for surgical instruments.

Indications for Use

Indicated for surgical soft tissue vaporization, incision, excision, cutting, hemostasis, and coagulation in patients requiring procedures in urology, thoracic surgery, plastic surgery, dermatology, aesthetics (vascular lesions, hair removal), general surgery, ophthalmology, orthopedics, podiatry, arthroscopy, spinal surgery, gynecology, pulmonary surgery, neurosurgery, gastroenterology, radiology, endovascular coagulation, oral surgery, dental procedures, and laser-assisted lipolysis.

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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

## JUL 1 6 2010

Eufoton S.R.L. % Mr. Paolo Cossich Via Flavia 23/1 Trieste, Italy 34148

Re: K092860

Trade/Device Name: Lasemar 800, 1000, 1500 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and Plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: July 09, 2010

Received: July 15, 2010

Dear Mr. Cossich:

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, Or ug 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. 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, FIDA 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

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Page 2 - Mr. Paolo Cossich

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Yavinal S. Chapman

FOR M:

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): K 092860

DEVICE NAME:

Lasemar 800, Lasemar 1000, Lasemar 1500

Indications for use

The Lasemar 800, Lasemar 1000, Lasemar 1500 (and the fiber delivery systems and accessories used to deliver laser energy), are indicated for :surgical applications requiring the vaporization, incision, excition, cutting and hemostation, cutting and hemostasis, or specialistion of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracion who endoscopic equipment for medical
Aesthelics including: Urology, Thoracio Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedias, Podiatry, Arthroscopy, Spinal Surgery,
Ophthalmology, Orthopedics, Podiator, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Spinel Radiology, Endovascular coagulation, Oral Surgery, Dental procedures and Laser
Assisted Linolysis Assisted Lipolysis.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign-Off

(Division Sign-Off) Division of Surgisal, Orthopedic, and Restorative Devices

510(k) Number K092860