E-BEAM ND: YAG LASER

K122922 · Eclipse Aesthetics, LLC · GEX · Jan 10, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K122922
• Device Name: E-BEAM ND: YAG LASER
• Applicant: Eclipse Aesthetics, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jan 10, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Tri-Beam Nd:YAG 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 Caff-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

Device Story

The Tri-Beam Nd:YAG Laser System is a Q-switched laser device used in clinical dermatology and surgical settings. It operates at 1064nm and 532nm wavelengths, with optional dye attachments for 585nm and 650nm. The system includes a main console, color touch screen, articulated arm handpiece, and footswitch. It functions in both Q-switched and long-pulse modes. The physician operates the device to deliver laser energy to target tissues; the beam profile is 'Top Hat' mode. The device is used for various dermatological procedures, including tattoo removal, lesion treatment, and skin resurfacing. Clinical decision-making is guided by the physician's assessment of the patient's skin condition and the appropriate wavelength/energy settings. The device provides therapeutic benefits by enabling precise tissue ablation, coagulation, and pigment targeting.

Clinical Evidence

No clinical data.

Technological Characteristics

Nd:YAG laser system; Q-switched and long-pulse operating modes; wavelengths 1064nm/532nm (optional 585nm/650nm); Top Hat beam profile; articulated arm delivery; 655nm red diode aiming beam (1mW); pulse width 5-10ns (Q-switched) and 300us (long pulse); pulse energy up to 1500mJ; color touch screen interface.

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 ink colors), removal of epidermal pigmented lesions, minor vascular lesions (telangiectasias), lentigines, cafe-au-lait, seborrheic keratoses, post-inflammatory hyper-pigmentation, Becker's nevi, freckles, nevi spilus, nevus of Ota, hair removal/lightening, common nevi, and skin resurfacing for acne scars and 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 Spectra Laser System (K113588)

Submission Summary (Full Text)

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K 122922

#### Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System

## JAN 1 0 2013

This 510(K) Summary of safety and effectiveness for the E-Beam Nd:YAG Laser System is submitted in accordance with the requirements of the SMDA 1990 and following guidance concerning the organization and content of a 510(K) summary.

Applicant:

Eclipse Aesthetics, LLC

Address:

13988 Diplomat Drive Suite 160 Dallas, TX 75234

Contact Person:

Telephone: Fax: Email:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Legally Marketed Predicate Device:

Description of the E-Beam Nd:YAG Laser System:

Intended use of the E-Beam Nd:YAG Laser System:

Mr. Tom O'Brien

972-380-2911 - phone [phone] - fax [e-mail]

September 12, 2012

E-Beam Nd: YAG Laser System

Nd:YAG Q-Switch Laser

Instrument. Surgical, Powered, laser 79-GEX, 21 CFR 878-48

Lutronic Spectra Laser System K113588

The E-Beam Nd:YAG Laser System is a O-Switch laser with wavelengths of 1064nm and 532nm. Optional Dye attachments to the handpiece add additional wavelengths of 585nm and 650nm. This system consists of main body, color touch screen, articulated arm hand-piece and Foot switch.

The E-Beam Nd:YAG Laser System can also be used in a long pulse mode.

The E-Beam Nd:YAG Laser System in indicated for: the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coaqulation and hemostasis.

532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dve 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 Cafe-Au-Lait .
- Treatment of Seborrheic Keratoses ●

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#### Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System

- 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

Performance Data: Results of Clinical Study: Conclusion:

None None

None

The E-Beam Nd:YAG Laser System is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.

Technical Comparison for the Q-Switch Laser

| Feature | Wavelength | E-Beam<br>(Subject of this submission) | Spectra (K113588)<br>(Predicate Device) |
|----------------|------------|------------------------------------------|-------------------------------------------|
| Laser Medium | | Nd:YAG | Nd: YAG |
| Wavelengths | | 1064nm / 532nm<br>(Option: 585nm, 650nm) | 1064nm / 532nm<br>(Option: 585nm, 650nm) |
| Operating Mode | | Q-Switched | Q-Switched |
| Beam Profile | | Top Hat Mode | Top Hat Mode |
| Pulse Energy | 1064nm | 1200mJ | 1200mJ |
| | 532nm | 400mJ | 400mJ |
| | 585nm | 250 mJ | 250mJ |
| | 650nm | 150mJ | 150mJ |
| Pulse Width | | 5ns - 10ns | 5ns - 10ns |
| Spot Size | 1064nm | 2-8mm<br>Collimated: 6mm | 3,4,5,6,7,8mm<br>Optional: 1,2,3,4,6,7,mm |
| | 532nm | 6.9mm | |
| | 585nm | | 2mm |
| | 650nm | 2mm | 2mm |
| Pulse Duration | 1064nm | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz |
| | 532nm | Single, 1,2,4,5Hz | Single, 1,2,4,5,Hz |
| | 585nm | Single, 1,2,4,5 Hz | Single, 1,2,4,5 Hz |
| | 650nm | Single, 1 and 2Hz | Single, 1 and 2Hz |
| Beam Delivery | | Articulated Arm | Articulated Arm |
| Aiming Beam | | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW |

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#### Attachment 5 510(K) Summary E-Beam Nd:YAG Laser System

Technical Comparison for the Long Pulse Nd:YAG

.

i

| Feature | E-Beam<br>(Subject of this submission) | Spectra (K113588)<br>(Predicate Device) |
|-----------------|----------------------------------------|-------------------------------------------|
| Laser Medium | Nd:YAG | Nd:YAG |
| Wavelengths | 1064nm | 1064nm |
| Operating Mode | Long Pulse | Long Pulse |
| Beam Profile | Top Hat Mode | Top Hat Mode |
| Pulse Energy | 1500mJ | 1500mJ |
| Pulse Width | 300us | 300us |
| Spot Size | 2-8mm<br>Collimated 6mm | 3,4,5,6,7,8mm<br>Optional: 1,2,3,4,6,7,mm |
| Pulse Duration | Single, 1,2,5,10 Hz | Single, 1,2,5,10 Hz |
| Optical Deliver | Articulated Arm | Articulated Arm |
| Aiming Beam | Diode 655nm (Red) 1mW | Diode 655nm (Red) 1mW |

Conclusion:

The E-Beam Nd:YAG Laser System is substantially equivalent to the previously cleared predicate devices that are currently in commercial distribution.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: January 10, 2013

Eclipse Aesthetics, LLC % Mr. Tom O'Brien Chief Executive Officer 13998 Diplomat Drive Dallas, Texas 75234

Re: K122922

Trade/Device Name: Tri-Beam Nd: YAG 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: Class II Product Code: GEX Dated: December 05, 2012 Received: December 11, 2012

Dear Ms. O'Brien:

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. 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 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); medical device reporting (reporting of medical

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Page 2 - Mr. Tom O'Brien

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 N. Melkerson

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

#### 510(k) Number (if known): K122922

Device Name: Tri-Beam Nd:YAG Laser System

Indications for Use:

The Tri-Beam Nd:YAG 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 Caff-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

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Neil R Ogden 2013.01.04 1'4:51:12 -05'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number _ K122922

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