SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM

K073436 · Lutronic Corporation · GEX · Dec 28, 2007 · General, Plastic Surgery

Device Facts

• Record ID: K073436
• Device Name: SPECTRA VRMII 1-SWITCHED ND:YAG LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Dec 28, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Spectra VRMII Laser System in indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. - 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions 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: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of 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 VRMII is a Q-switched Nd:YAG laser system producing pulsed coherent light at 1064nm and 532nm. Device uses articulated arm and handpiece to deliver energy to target chromophores (melanin, tattoo particles) in human tissue. Rapid localized heating causes fragmentation of chromophores. Physician controls laser pulse energy and spot size to optimize treatment for specific dermatological and surgical applications. Used in clinical settings by physicians for procedures including tattoo removal, skin resurfacing, and soft tissue ablation. Output allows for precise coagulation, hemostasis, and tissue modification, providing therapeutic benefits for pigmented lesions, vascular conditions, and aesthetic skin concerns.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser system; dual wavelength output at 1064nm and 532nm; articulated arm delivery system with interchangeable handpieces; energy source is a powered laser; device is a standalone surgical instrument.

Indications for Use

Indicated for soft tissue incision, excision, ablation, vaporization, coagulation, and hemostasis in general dermatology and surgery. Specific applications include tattoo removal (various colors), epidermal pigmented lesions, vascular lesions, lentigines, café-au-lait spots, seborrheic keratoses, post-inflammatory hyper-pigmentation, Becker's nevi, freckles, nevi spilus, nevus of Ota, hair lightening, common nevi, and acne scar/wrinkle resurfacing.

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 Spectra QT Q-switched Nd: YAG Laser System
• Tissue Medical Spectra-VRM Q-switched Nd: Y AG Laser System
• Altus Medical CoolGlide Aesthetic Lasers
• Fotona QX Nd: YAG/KTP Laser System
• NaturaLase LP with 532 Hand Piece

Submission Summary (Full Text)

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DEC 28 2007

K073436 page 1/2

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

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 #403-2,3,4, Ilsan Technotown 1141-1 Baeksok-Dong, Ilsan-Gu Goyang-Si, Gyeonggi-Do, 410-722 Republic of Korea

Contact Person:

Maureen O'Connell O'Connell Regulatory Consultants, Inc. 5 Timber Lane North Reading, MA 01864 Telephone: [phone] Fax: [phone]

Summary Preparation Date:

December 20, 2007

2. Names

Device Name:

Spectra VRMII (Q-Switched Nd:YAG) Laser System

Classification Name:

Laser Instrument, Surgical, Powered Product Code: GEX Panel: General & Plastic Surgery

## 3. Predicate Devices

The Spectra VRMII Laser System is substantially equivalent to the Lutronic Spectra QT Q-switched Nd: YAG Laser System, the Tissue Medical Spectra-VRM Q-switched Nd: Y AG Laser System, the Altus Medical CoolGlide Aesthetic Lasers, the Fotona QX Nd: YAG/KTP Laser System and the NaturaLase LP with 532 Hand Piece.

## 4. Device Description

The Spectra VRMII 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. When the

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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 VRMII 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 : Removal of light ink (Red, Tan, Purple, and Orange)
Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions 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: Removal of dark ink (Black, Blue and Brown)

Tattoos

Removal of Nevus of Ota

Removal of lightening of unwanted hair with or without

adjuvant preparation.

Treatment of Common Nevi

Skin resurfacing procedures for the treatment of acne scars and wrinkles

6. Performance Data

None presented.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other.

DEC 2 8 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K073436

Trade/Device Name: Spectra VRMII Laser System Regulatory Number: 21 CFR 878.4810 Regulatory Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: December 5, 2007 Received: December 6, 2007

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 Mullerson

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): K073436

Device Name: Spectra VRMII Laser System

Indications for Use:

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

- 532nm Wavelength : Removal of light ink (Red, Tan, Purple, and Orange) Tattoos Removal of Epidermal Pigmented Lesions Removal of Minor Vascular Lesions 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: Removal of dark ink (Black, Blue and Brown) Tattoos Removal of Nevus of Ota Removal of lightening of unwanted hair with or without adjuvant preparation. Treatment of Common Nevi Skin resurfacing procedures for the treatment of acne scars and wrinkles

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)

Larry D. Taylor

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(Division Sign-Off) Division of General, Restorative, and Neurological Devices

K073436 510(k) Number