MULTILASER SYSTEM

K123777 · Ultralight Laser Technologies, LLC · GEX · Apr 11, 2013 · General, Plastic Surgery

Device Facts

• Record ID: K123777
• Device Name: MULTILASER SYSTEM
• Applicant: Ultralight Laser Technologies, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 11, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery). The Nd:YAG handpiece is indicated for: At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented lesions and the removal or lightening of hair. At the 532 nm wavelength removal of red ink tattoos, treatment of vascular lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes). The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for: Hair Removal, Permanent hair reduction, Treatment of vascular lesions, Treatment of benign pigmented lesions, Treatment of Leg Veins, Treatment for pseudofolliculitis barbae. The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications: Hair Removal (650nm filter), Permanent hair reduction (650nm filter), Treatment of vascular lesions (510nm filter), Treatment of benign pigmented lesions (510 nm filter), Mild to Moderate inflammatory acne (450nm filter).

Device Story

MultiLaser System is a console-based surgical laser platform featuring four interchangeable handpieces: Er:YAG, Nd:YAG, Diode, and IPL. The console houses power supply, control electronics, and user interface. The system delivers light energy to target skin tissues for ablation, coagulation, vaporization, or cutting. Operated by physicians in clinical settings (dermatology/plastic surgery), the device allows practitioners to select specific wavelengths and pulse parameters via the console to treat various dermatological conditions, including tattoos, vascular lesions, and unwanted hair. The output is controlled by the clinician to achieve therapeutic thermal effects on the skin, potentially benefiting patients by improving skin appearance, removing unwanted hair, or treating specific vascular/pigmented lesions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Console-based system with four handpieces: Er:YAG (2940nm), Nd:YAG (1064nm/532nm), Diode (810nm), and IPL (450-1200nm). Energy delivery via light guide or direct beam. Features include variable pulse widths, repetition rates (1-5Hz for Nd:YAG, up to 10Hz for Er:YAG), and multiple spot sizes. Aiming beam provided by HeNe laser. System is powered, class II surgical instrument.

Indications for Use

Indicated for dermatology and plastic surgery patients requiring soft tissue ablation, coagulation, or vaporization; tattoo removal; hair removal/reduction; treatment of vascular lesions (veins, angiomas, port wine stains); treatment of benign pigmented lesions; and treatment of mild to moderate inflammatory acne. Applicable to Fitzpatrick Skin Types I-VI (Diode) or I-IV (IPL).

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

• TriPlex Laser System (K110502)
• Apex Laser System (K110304)
• Cheveux Laser System (K100893)

Submission Summary (Full Text)

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#### Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

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ﻴﺔ

# This 510(K) Summary of safety and effectiveness for the MultiLaser 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. UltraLight Laser Technologies, LLC Applicant: UltraLight Laser Technologies LLC 105 Citation Court

Contact Person:

Telephone: Fax: Email:

K123777

Address:

Preparation Date:

Device Trade Name:

Common Name:

Classification Name:

Classification

Legally Marketed Predicate Device(s):

Description of the MultiLaser System:

Intended use of the MultiLaser System

The MultiLaser System consists of a console that houses the power supply, control electronics and user interface and four separate handpiece. The four handpieces consist of an Er:YAG laser handpiece, an Nd:YAG laser handpiece, a Diode laser handpiece and an IPL handpiece.

The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

- At the 1064 nm wavelength dark ink tattoo . removal, removal of pigmented lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink . tattoos, treatment of vascular lesions including facial
- ર- I

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Mr. Mark Rohrer

1-205-356-1172 1-205-356-1171 [e-mail]

Birmingham, AL 35209

November 30, 2012

MultiLaser System

Laser

Instrument, Surgical, Powered, laser GEX, 21 CFR 878.4810

Powered light based non-laser surgical instrument with thermal effect ONF, 21 CFR 878.4810

TriPlex Laser System (K)110502 Apex Laser System (K)110304 Cheveux Laser System (K)100893

Class II

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# Attachment 5

# 510(K) Summary as required by section 807.92(c).

MultiLaser System

#### Page 2 of 4

and leq veins. telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:

- . Hair Removal
- . Permanent hair reduction
- Treatment of vascular lesions .
- . Treatment of benign pigmented lesions
- . Treatment of Leg Veins
- . Treatment for pseudofolliculitis barbae

The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale following . for the indications:

- Hair Removal .
- (650nm filter)
- Permanent hair reduction . (650nm filter)
- . Treatment of vascular lesions (510nm filter)
- . Treatment of benign pigmented lesions (510 nm filter)
- . Mild to Moderate inflammatory acne (450nm filter)

Performance Data:

None

None

Results of Clinical Study:

Technical Specifications Comparison:

K123777

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## Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

K123777

ﮯ ،

Nd:YAG Handpiece Specification

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| | UltraLight LLC Multi-Laser System | Sandstone Medical Technologies<br>LLC TriPlex (K110502) |
|-----------------|------------------------------------------------------|---------------------------------------------------------|
| Energy | Up to 1000mJ | Up to 1000mJ |
| Maximum Fluence | 12J/cm2 | 12J/cm2 |
| Wavelength | 1064nm and 532nm | 1064nm and 532nm |
| Spot Size | up to 5mm | up to 5mm |
| Pulse Width | 10ns | 10ns |
| Pulsewidth | Single pulse and variable . 0.06 sec<br>- continuous | Single pulse and variable . 0.06 sec<br>- continuous |
| Repetition Rate | 1-5Hz | 1-5Hz |
| Aiming Beam | HeNe | HeNe |

Diode Laser Handpiece Specification

| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC<br>Cheveux (K100893) |
|----------------------|--------------------------------------|------------------------------------------------------------|
| Light Source | Diode Array | Diode Array |
| Wavelength | 810nm | 810nm |
| Energy Density | Up to 100J/cm² | Up to 100J/cm² |
| Spot Size | 14x 10 mm | 14x 10 mm |
| Pulse Width | Up to 400ms | Up to 400ms |
| Beam Delivery System | Light Guide | Light Guide |

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### Attachment 5 510(K) Summary as required by section 807.92(c). MultiLaser System

## K123777

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#### Er:YAG Laser Handpiece Specification

| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC TriPlex<br>(K110502) |
|-----------------|--------------------------------------|------------------------------------------------------------|
| Wavelength | 2940nm | 2940nm |
| Max Power | 2.4 W | 2.4 W |
| Max Fluence | 8 J/cm2 | 8 J/cm2 |
| Pulse Width | 300 μs | 300 μs |
| Repetition Rate | Up to 10 pulse per second | Up to 10 pulse per second |
| Spot Size | 1.5mm, 3mm, 6mm, 9mm | 1.5mm, 3mm, 6mm, 9mm |

## Intense Pulsed Light (IPL) Handpiece Specification

| | UltraLight LLC Multi-Laser<br>System | Sandstone Medical<br>Technologies LLC Apex<br>(K110304) |
|--------------------|--------------------------------------|---------------------------------------------------------|
| Light Source | Pulsed Incoherent Light | Pulsed Incoherent Light |
| Max Fluence | Up to 35J/cm² | Up to 35J/cm² |
| Wavelength | 450 - 1200 nm | 450 - 1200 nm |
| Spot Size | 35 x 15 mm² | 35 x 15 mm² |
| Pulse Width | Up to 200ms | Up to 200ms |
| Beam Delivery Stem | Light Guide | Light Guide |

Conclusion:

The MultiLaser System is substantially equivalent to other existing laser and IPL systems in commercial distribution for use in Dermatology and Plastic Surgery.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the department's name, which is arranged in a circular pattern around the left side of the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

UltraLight Laser Technologies, LLC % Mr. Mark Rohrer 105 Citation Court Birmingham, Alabama 35209

April 11, 2013

Re: K123777

Trade/Device Name: MultiLaser 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: February 21, 2013 Received: March 11, 2013

Dear Mr. Rohrer:

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

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Page 2 – Mr. Mark Rohrer

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/ResourcesforYou/Industry/default.htm.

Sincerely yours, FOR

PeterD.Rumm-S

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): K123777

Multi-Laser Laser System Device Name:

The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

The Nd:YAG handpiece is indicated for:

- At the 1064 nm wavelength dark ink tattoo removal, removal of pigmented . lesions and the removal or lightening of hair.
- At the 532 nm wavelength removal of red ink tattoos, treatment of vascular . lesions including facial and leg veins, telangiectasias, angiomas, hemangiomas, port wine stains and most pigmented lesions (e.g. lentigies, ephildes)

The Diode laser is indicated for use on all skin types (Fitzpatrick Skin Types I-VI) including tanned skin for:

- Hair Removal .
- Permanent hair reduction ●
- Treatment of vascular lesions .
- · · Treatment of benign pigmented lesions
- . Treatment of Leg Veins
- Treatment for pseudofolliculitis barbae ●

Neil R Ogdens // 0 10 11:21 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777

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The IPL Handpiece is indicated for use in skin types I-IV according to the Fitzpatrick Scale for the following indications:

- Hair Removal .
- Permanent hair reduction .
- . Treatment of vascular lesions
- Treatment of benign pigmented lesions .
- Mild to Moderate inflammatory acne .

(650nm filter) (650nm filter) (510nm filter) (510 nm filter) (450nm filter)

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

Over-The-Counter Use (21 CFR 807 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 Ogder 2013.04.10 10:14:45 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K123777

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