SPECTRA LASER SYSTEM

K113588 · Lutronic Corporation · GEX · Feb 22, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K113588
• Device Name: SPECTRA LASER SYSTEM
• Applicant: Lutronic Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 22, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SPECTRA 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 (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 wrinkle -Treatment of melasma.

Device Story

SPECTRA Laser System is a Q-switched Nd:YAG laser producing 1064 nm and 532 nm pulsed coherent light; optional dye handpieces convert 532 nm to 585 nm or 650 nm. Device operates by delivering laser energy to target chromophores (melanin, tattoo particles) in human tissue; rapid localized heating causes fragmentation of chromophores. Physician controls treatment fluence, pulse energy, and spot size via handpiece to optimize clinical effect. Used in clinical settings by physicians for dermatologic and surgical procedures. Output allows for precise tissue ablation, coagulation, and pigment/tattoo removal. Benefits include effective treatment of various pigmented lesions, vascular lesions, and skin resurfacing.

Clinical Evidence

No clinical data presented; bench testing only.

Technological Characteristics

Q-switched Nd:YAG laser; wavelengths 1064 nm and 532 nm; optional dye handpieces for 585 nm and 650 nm. Articulated arm delivery system. Energy source: electrical. Device is a surgical laser instrument.

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), epidermal pigmented/vascular lesions, lentigines, café-au-lait spots, seborrheic keratoses, post-inflammatory hyper-pigmentation, nevi (Becker's, Spilus, Common, Ota), hair removal/lightening, acne scar/wrinkle resurfacing, and melasma treatment.

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 Laser System (K103455)
• Palomar Medical Technologies, Inc. Q-YAG 5 (K061436)

Submission Summary (Full Text)

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

K113588

FEB 2 2 2012

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>Room 403-1,2,3,4,5, 404 Ilsan Technotown<br>1141-1, Baekseok-dong, Ilsandong-gu,<br>Goyang-si, Gyeonggi-do, 410-722<br>Republic of Korea |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Jhung Won Vojir, Ph.D<br>Chief Executive Officer<br>Lutronic, Inc.<br>Six Neshaminy Interplex, Suite<br>Trevose, PA 19053<br>Telephone: [phone]<br>Fax: [phone] |
| Summary Preparation Date: | December 2, 2011 |
| Names | |
| Device Name: | SPECTRA Q-Switched Nd:YAG<br>Laser System with Dye Handpieces |
| Classification Name: | Laser Instrument, Surgical, Powered<br>Product Code: GEX |

#### 3. Predicate Devices

2

The SPECTRA Laser System is substantially equivalent to the Lutronic Corporation SPECTRA Laser System (K103455) and Palomar Medical Technologies, Inc. Q-YAG 5 (K061436).

## 4. Device Description

The SPECTRA Laser System produces a pulsed beam of coherent near infrared 11064 nm) and visible (532nm) light. This beam is directed to the treatment zone (100 Film) and risulated arm coupled to a handpiece. In addition, two dye

Panel: General & Plastic Surgery

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handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm.

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.

#### Indications for Use 5.

The SPECTRA 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 i

-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 wrinkle

-Treatment of melasma.

## 6. Substantial Equivalence

The SPECTRA Laser System is substantially equivalent to the SPECTRA Laser System cleared in K103455 and the Palomar Q-YAG 5 Laser System cleared in Bystem freared the SPECTRA Laser System has the same indications statement as the

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SPECTRA Laser System cleared in K103455 with the exception of the melasma indication for use which is being added for the 1064 nm wavelength in this 510(k). The SPECTRA Laser System has the same intended use as the Palomar Q-YAG 5 (K061436) with minor differences in the indications for use statement. Both the SPECTRA and the Palomar Q-YAG 5 are intended for the incision, excision, ablation, and vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis. The SPECTRA Laser System has the same technological characteristics as the predicate devices. All three devices are Q-switched Nd: YAG lasers operating at wavelength of 1064 nm and 532 nm. Additionally, all three devices have dye handpieces that convert the 532 nm wavelength beam into 585 nm or 650 nm wavelengths. The SPECTRA Laser System has the exact technological characteristics as the previously cleared SPECTRA Laser System (K103455). The SPECTRA Laser System has similar technological characteristics to the Q-YAG 5 predicate. The SPECTRA Laser System is substantially equivalent to the predicate devices.

7. Performance Data None presented.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an eagle emblem, which is a symbol of the United States. The eagle is depicted in a stylized manner, with its wings spread and its head turned to the right.

#### Public Health Service

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

FEB 2 2 2012

Lutronic Corporation % Lutronic, Inc. Jhung Won Vojir 6 Neshaminy Interplex, Suite 207 Trevose, Pennsylvania 19053

Re: K113588

Trade/Device Name: SPECTRA 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: December 2, 2012 Received: December 5, 2012

Dear Jhung Won Vojir:

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 I va may , aronerols 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, 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 r hat FDA has made a determination that your device complies with other requirements of the Act

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## Page 2 - Jhung Won Vojir

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,

Mark McMullen

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

ા ૩૬૫૫૮ 510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________ SPECTRA Laser System

#### Indications for Use:

The SPECTRA Laser System in indicated for: the incision, excision, ablation, The of DOTTE Laber 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

- Treatment or Sommedures for the treatment of acne scars and wrinkle

-Treatment of melasma

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

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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)

Nilson Diniz firmino
Page 1 of 1

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113588

Confidential and Proprietary Information for Lutronic Corporation