SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES

K080248 · Lutronic Corporation · GEX · Apr 23, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K080248
• Device Name: SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. - 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces): - Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) - Removal of Epidermal Pigmented Lesions - Removal of Minor Vascular Lesions including but not limited to telangiectasias - Treatment of Lentigines - Treatment of Café-Au-Lait - Treatment of Seborrheic Keratoses - Treatment of Post Inflammatory Hyper-Pigmentation - Treatment of Becker's Nevi, Freckles and Nevi Spilus - 1064nm Wavelength: - Tattoo removal: dark ink (black, blue and brown) - Removal of Nevus of Ota - Removal or lightening of unwanted hair with or without adjuvant preparation. - Treatment of Common Nevi - Skin resurfacing procedures for the treatment of acne scars and wrinkles

Device Story

Spectra VRMIII Laser System produces pulsed coherent 1064nm and 532nm light; optional dye handpieces convert 532nm to 585nm or 650nm. Physician-operated in clinical settings; beam directed via articulated arm and handpiece to target tissue. Energy absorption by melanin and tattoo particles causes localized heating and fragmentation of chromophores. Physician controls laser pulse energy and spot size to optimize treatment effect. Device facilitates dermatologic procedures including tattoo removal, lesion treatment, hair removal, and skin resurfacing. Clinical benefit derived from precise tissue ablation and pigment fragmentation.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser; wavelengths 1064nm and 532nm (expandable to 585nm/650nm via dye handpieces). Energy delivered via articulated arm and handpiece. System allows manual adjustment of fluence and spot size. No software-based automated analysis or connectivity described.

Indications for Use

Indicated for patients requiring soft tissue incision, excision, ablation, vaporization, coagulation, or hemostasis in dermatology/general surgery. Specific applications include tattoo removal (various ink colors), pigmented/vascular lesion removal, hair removal, and skin resurfacing for acne scars/wrinkles.

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

• Lutronic Corporation Spectra VRMII Q-Switched Nd: YAG Laser System
• HOYA ConBio MedLite C6 Laser System
• RevLite Laser System

Submission Summary (Full Text)

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K 080248

## 510(k) Summary for the Lutronic Corporation Spectra VRMIII Laser System

APR 2 3 2008

This 510(k) Summary is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

## 1. General Information

| | Submitter: | Lutronic Corporation<br>#403-2,3,4, Ilsan Technotown<br>1141-1 Baeksok-Dong, Ilsan-Gu<br>Goyang-Si, Gyconggi-Do, 410-722<br>Republic of Korea |
|----|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Maureen O'Connell<br>O'Connell Regulatory Consultants, Inc.<br>5 Timber Lane<br>North Reading, MA 01864<br>Telephone: [phone]<br>Fax: [phone] |
| | Summary Preparation Date: | April 16, 2008 |
| 2. | Names | |
| | Device Name: | Spectra VRMIII Laser System |
| | Classification Name: | Laser Instrument, Surgical, Powered<br>Product Code: GEX<br>Panel: General & Plastic Surgery |

### 3. Predicate Devices

The Spectra VRMIII Laser System is substantially equivalent to the Lutronic Corporation Spectra VRMII Q-Switched Nd: YAG Laser System, the HOYA ConBio MedI.ite C6 Laser System and the RevLite Laser System.

### 4. Device Description

The Spectra VRMIII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm.

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When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles.

By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.

#### 5. Indications for Use

The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

- 532nm Wavelength (nominal delivered energy of 585 nm and 650 mm with . optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) 0
- Removal of Epidermal Pigmented Lesions ্
- Removal of Minor Vascular Lesions including but not limited to O telangiectasias
- Treatment of Lentigines 0
- Treatment of Café-Au-Lait o
- Treatment of Seborrheic Keratoses ்
- Treatment of Post Inflammatory Hyper-Pigmentation ಂ
- Treatment of Becker's Nevi, Freckles and Nevi Spilus o
- 1064nm Wavelength: .
- Tattoo removal: dark ink (black, blue and brown) ం
- Removal of Nevus of Ota o
- Removal or lightening of unwanted hair with or without adjuvant 0 preparation.
- Treatment of Common Nevi o
- Skin resurfacing procedures for the treatment of acne scars and wrinkles o

## 6. Performance Data

None presented.

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Image /page/2/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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# APR 2 3 2008

Lutronic Corporation % O'Connell Regulatory Consultants, Inc. Ms. Maureen O'Connell Regulatory Consultant 5 Timber Lane North Reading, Massachusetts 01864

Re: K080248 Trade/Device Name: Spectra VRMIII 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: March 11, 2008 Received: March 12, 2008

Dear Ms. O'Connell:

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

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Page 2 - Ms. Maureen O'Connell

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N. Millman

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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#### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

K080248

Device Name: Spectra VRMIII

#### Indications for Use:

The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.

- 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with ● optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green) o
- Removal of Epidermal Pigmented Lesions o
- Removal of Minor Vascular Lesions including but not limited to O telangiectasias
- Treatment of Lentigines o
- Treatment of Café-Au-Lait o
- Treatment of Seborrheic Keratoses o
- Treatment of Post Inflammatory Hyper-Pigmentation O
- Treatment of Becker's Nevi, Freckles and Nevi Spilus O
- 1064nm Wavelength:
- Tattoo removal: dark ink (black, blue and brown) o.
- Removal of Nevus of Ota o
- Removal or lightening of unwanted hair with or without adjuvant O preparation.
- Treatment of Common Nevi O
- Skin resurfacing procedures for the treatment of acne scars and wrinkles O

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

Over The Counter Use (Part 21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R. Ogden for xmm
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(Division S Division of General, Restorative, and Neurological Devices

510(k) Number K080248