VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES

K063396 · Lasering S.R.L. · GEX · Jan 17, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K063396
• Device Name: VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES
• Applicant: Lasering S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 17, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.

Device Story

Velure Family of Diode Lasers are surgical laser systems emitting coherent light at 532nm, 808nm, or 980nm. System comprises a console containing a diode laser, 635nm pilot laser, micro-controller, air cooling, and power supply; SMA fiber delivery system; handpieces; footswitch; and safety goggles. Operated by clinicians in surgical or clinical environments. Device transforms electrical energy into laser light for soft tissue interaction (ablation, coagulation, etc.). Clinician directs laser beam via handpiece to target tissue; output effects include tissue vaporization or coagulation. Benefits include precise surgical cutting and aesthetic treatment capabilities.

Clinical Evidence

No clinical data provided. Bench testing only.

Technological Characteristics

Diode laser system; wavelengths: 532nm, 808nm, 980nm. Includes 635nm pilot laser. Features micro-controller, air cooling, SMA fiber delivery, and footswitch. Class II device (GEX).

Indications for Use

Indicated for patients requiring soft tissue ablation, vaporization, excision, incision, and coagulation in dermatology, oral, periodontal, and general surgical settings. Specific applications include vascular and pigmented lesion treatment, hair removal, GYN, ENT, neuro, urology, and tooth whitening.

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

• Adept Ultralite 532 (K042496)
• Intermedic Diode Laser Family (K053540)

Submission Summary (Full Text)

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JAN 1 7 2007

### 510(k) Summary of Safety and Effectiveness for the Velure Family of Diode Lasers and Delivery Device Accessories

#### 1. General Information

| Submitter: | Lasering S.r.l<br>Via Staffette Partigiane, 54<br>Modena, 4110 Italy |
|------------|----------------------------------------------------------------------|
|------------|----------------------------------------------------------------------|

Contact Person: Allen R. Howes TTI Medical 2246 Camino Ramon San Ramon, CA 94583 925-355-0750 (F) 925-355-0777

Preparation Date: November 6, 2006

#### 2. Device Name:

Trade/Proprietary Name: Velure Family of Diode Lasers and Delivery Device Accessories Common/Usual Name: General Surgical Laser System Classification Name: Laser Instrument, Surgical Powered Product Code: GEX Panel: 79

#### 3. Predicate Devices:

The Velure Family of Diode Lasers and deliver device accessories are substantially equivalent to the predicate devices Adept Ultralite 532 (K042496) and the Intermedic Diode Laser Family (K053540.

#### 4. Device Description:

The Velure Family of Diode Lasers emit a beam of coherent light in either continuous wave or pulse mode at the following wavelengths.

523nm - Velure S5

808nm - Velure S8/15, Velure S8/30 and Velure S800

980nm - Velure S9/7D, Velure S9/15, Velure S9/15D and Velure S9/30

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Each laser consists of a self-contained console, an SMA fiber delivery system with handpiece, a footswitch, safety goggles and warning label set. The main console contains a Diode laser, a 635nm pilot laser, micro-controller, air cooling system and power supply. The console has an on-off key switch and emergency stop push button. The SMA fiber delivery system connects the console to a variety of fiber optic handpieces and scanner (Velure S5 only). Refer to the enclosed brochures and instruction manuals for complete published information.

#### 5. Intended Use:

The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.

#### Velure S5

532nm (Green) Diode Laser

### Applications:

Vascular Lesions

Pigmented Lesions

Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser

### Applications:

Vascular Lesions

Unwanted Hair Removal

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### Velure S9/15 and Velure S9/30

980nm Diode Laser Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urology

Velure S9/7D and Velure S9/15D 980nm Diode Laser Applications: Oral and Periodontal Surgery

Bleaching (tooth whitening)

Specifications - Refer to pages 5 and 6 in the Instruction Manuals for published specifications

Performance Data: None provided 6.

7. Clinical Data: None provided

#### 8. Conclusion:

The Velure Family of Diode Lasers and delivery device accessories are substantially equivalent to predicate diode laser systems in commercial distribution for use in Dermatology, Aesthetic Surgery, Plastic Surgery, General Surgery, Dentistry, ENT, Neurosurgery and Gynecology.

j

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing its wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Lasering S.r.l. % Mr. Allen R. Howes TTI Medical 2246 Camino Ramon San Ramon, California 94583

JAN 17 2007

Re: K063396

Trade/Device Name: Velure Family of Diode Lasers and Delivery Device Accessories 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: November 6, 2006 Received: November 9, 2006

Dear Mr. Howes:

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, 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. Allen R. Howes

This letter will allow you to begin marketing your device as described in your Section 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), 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/industry/support/index.html.

Sincerely yours,

Qof

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

Enclosure

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510(k) Number K063396

Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.

Indications For Use:

The Velure Family of Diode Lasers are intended for use in dermatology, hair removal, oral, periodontal and surgical applications that require ablation, vaporization, excision, incision and coagulation of soft tissue.

Velure S5 532nm (Green) Diode Laser

Applications:

Vascular Lesions

Pigmented Lesions

Prescription Use
(part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) SIZIL= Division Page 1 of 4 Division of General, Restorative, and Neurological Devices 510 (k) Number.

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510(k) Number K063396

Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.

Indications For Use: Continued from previous page

Velure S8/15, Velure S8/30 and Velure S800 808nm Diode Laser

Applications: Vascular Lesions

Unwanted Hair Removal

Prescription Use (part21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

:

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

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ત્ત્વ-સ

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510(k) Number K 063396

Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.

Indications For Use: Continued from previous page

Velure S9/15, Velure S9/30 980mm Diode Laser

Applications: Surgical Cut and coagulate General Surgery GYN ENT Neuro Urgology

Prescription Use (part21 CFR 801 Subpart D)

### AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

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.

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510(k) Number K 063396

Device Name: Velure Family of Diode Lasers and Delivery Device Accessories.

Indications For Use: Continued from previous page

Velure S9/7D and Velure S9/15D 980nm Diode Laser

Applications: Oral and Periodontal Surgery

Bleaching (tooth whitening)

Prescription Use (part21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 801 Subpart C)

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

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