MDL SERIES DIODE LASERS, MODEL MDL-10/15

K042114 · Vision Lasertechnik, GmbH · GEX · Feb 3, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K042114
• Device Name: MDL SERIES DIODE LASERS, MODEL MDL-10/15
• Applicant: Vision Lasertechnik, GmbH
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 3, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MDL Laser System is intended for use as a dental laser, with specific application in oral soft tissue for incision, excision, vaporization, ablation and coagulation. Indications for use include the following: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Loukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty

Device Story

MDL Laser System is a diode laser for oral soft tissue surgery; performs incision, excision, vaporization, ablation, and coagulation. Used by dental professionals in clinical settings. Device delivers laser energy to target tissue to achieve surgical outcomes; provides hemostasis during procedures. Benefits include precise tissue management and reduced bleeding compared to traditional methods. Operates via practitioner-controlled interface.

Clinical Evidence

Bench testing only.

Technological Characteristics

Diode laser system; intended for soft tissue dental surgery. Class II device under 21 CFR 878.4810. Product code GEX.

Indications for Use

Indicated for dental patients requiring oral soft tissue procedures including biopsies, frenectomy, gingivectomy, implant recovery, pulpotomy, and treatment of oral ulcers/lesions. Prescription use only.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the Department of Health and Human Services. The seal features an abstract image of an eagle with three stripes forming its wings. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" are arranged in a circle around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 3 2006

Vision Lasertechnik, GmbH c/o Mr. Robert S. Head Agent Telestar Enterprises 8135 S. Beaumont Drive Sandy, Utah 84093

Re: K042114 Trade/Device Name: MDL Laser System Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 20, 2006 Received: January 26, 2006

Dear Mr. Head:

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. Isting 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.

{1}------------------------------------------------

Page 2 - Mr. Head

This letter will allow you to begin marketing your device as described in your Section 510(k) remarket 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" (21 CFR 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/industry/support/index.html.

Sincerely vours,

Barbara Buehrig

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known): K042114

MDL Series Diode Laser Device Name:

Indications For Use: The MDL Laser System is intended for use as a dental laser, with specific application in oral soft tissue for incision, excision, vaporization, ablation and coagulation. Indications for use include the following:

Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Loukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty

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)

Chouhare Buchun

Division of General. Re-orative. and Nourological Devices

Division of General, Restorative,
and Neuromuscular Dentistry

C

510 (k) Number _______________________________________________________________________________________________________________________________________________________________

Page 1 of 1