Lite Touch

K152737 · Focus Medical, LLC · GEX · Jun 29, 2016 · General, Plastic Surgery

Device Facts

• Record ID: K152737
• Device Name: Lite Touch
• Applicant: Focus Medical, LLC
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Jun 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Oral surgery; Gynecology; Otorhinolaryngology; Podiatry.

Device Story

Lite Touch is an Er:YAG laser treatment system (2940nm wavelength) used for soft tissue surgery. System comprises a cabinet containing laser source, control system, power supply, and internal cooling; beam delivered via counterbalanced articulated arm and handpiece. Operated by physicians in clinical settings. Two-stage activation process ensures control. Device vaporizes, excises, dissects, ablates, or photocoagulates soft tissue to facilitate surgical procedures across multiple specialties. Benefits include precise tissue interaction via pulsed laser energy. Physician monitors procedure via touchscreen interface; output affects clinical decision-making by enabling controlled tissue removal.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1 (general safety), IEC 60601-1-2 (EMC), IEC 60601-2-22 (surgical laser safety), IEC 60825-1 (laser safety), and IEC 62366/60601-1-6 (usability). No clinical data presented.

Technological Characteristics

Flashlamp-pumped solid-state Er:YAG rod laser; 2940nm wavelength; 24W power; 35-3000mJ energy; 300-1000us pulse duration; up to 16Hz frequency. Beam delivery via articulated arm. Water/air heat exchanger cooling. Touchscreen GUI. Complies with 21 CFR 1040.10/1040.11 and various IEC/EN standards for medical electrical equipment and laser safety.

Indications for Use

Indicated for soft tissue vaporization, incision, excision, dissection, ablation, and photocoagulation in dermatology, cosmetic, plastic, general, oral, and gynecological surgery, otorhinolaryngology, and podiatry. No specific patient population age or gender restrictions stated.

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

• Asceplion MCL 31 Dermablate (K150140)

Submission Summary (Full Text)

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

June 29, 2016

Focus Medical LLC Mr. John Lee Owner 23 Francis J. Clarke Circle Bethel, Connecticut 06801

Re: K152737

Trade/Device Name: Lite Touch 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: May 5, 2016 Received: May 23, 2016

Dear Mr. Lee:

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 device

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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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) K152737

#### Device Name

Lite Touch™ Er YAG Laser Treatment System

#### Indications for Use (Describe)

Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

- · Dermatology
- · Cosmetic surgery
- · Plastic and general surgery
- · Oral surgery
- · Gynecology
- · Otorhinolaryngology
- · Podiatry

Type of Use (Select one or both, as applicable)|X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510k Summary (21 CFR 807.92c)

| Submitter: | Focus Medical |
|----------------------------|---------------------------------------------------------|
| Address: | 23 Frances J. Clarke Circle<br>Bethel, CT, USA<br>06801 |
| Phone: | 203-730-8885 |
| Fax: | 203-730-8851 |
| Date Prepared: | 11 January 2016 |
| Name of Submission Device: | Lite Touch™, previously cleared under K974460 |
| Trade or Proprietary Name: | Lite Touch™ |
| Common/Usual Name: | Lite Touch™ Er:YAG Laser Treatment System |
| Classification: | Class II |
| Regulation: | 21 CFR 878.4810 |
| Product Code: | GEX |
| Classification Name: | Powered Laser Surgical Instrument |
| Review Panel: | General and Plastic Surgery |
| Predicate Device: | Asceplion MCL 31 Dermablate (K150140) |

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### Device Description:

The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry.

The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.

### Indications for Use:

Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, incision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties:

- . Dermatology
- Cosmetic surgery ●
- Plastic and general surgery
- . Oral surgerv
- . Gynecology
- Otorhinolaryngology
- Podiatry

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Technological Characteristics:

| Performance Characteristic | Lite Touch™ | MCL 31 Dermablate |
|--------------------------------|-----------------------------------------|-----------------------------------------|
| 510K | Not assigned | K150140 |
| Manufacturer | Focus Medical LLC | Asclepion Laser Technologies |
| Power | 24w | 20w |
| Energy (pulse and super pulse) | 35-3000 mJ | 2500mj max |
| Length of Pulse | 300-1000us | 100-1000us |
| Frequency of Pulse | Up to 16 Hz | 20 Hz |
| Spot size at target | 4, 6, 8, 10 mm | 1 – 12mm |
| Wavelength | 2940 nm | 2940 nm |
| Output mode | Pulsed | Pulsed |
| Beam delivery | Articulated Arm | Articulated Arm |
| Aiming Beam | 635 nm | 650nm |
| Laser medium | Flashlamp pumped solid state Er:YAG rod | Flashlamp pumped solid state Er:YAG rod |
| Cooling methods | Water/air heat exchanger | Water/air heat exchanger |
| Display/User Interface | Graphic user interface touchscreen | Graphic user interface touchscreen |
| Power calibration | Internal | Internal |

The subject and predicate device K150140 use similar technology, and differences between the subject and predicate device do not raise any new types of questions regarding safety or effectiveness for the subject device's intended use.

### Testing Performance:

The Lite Touch TM device for this 510(k) submission is fundamentally unchanged from the device that was cleared under K974460. The Lite Touch TM is in compliance with the requirements of 21 CFR 1040.10 -Performance Standards for light-Emitting Products, and with 21 CFR 1040.11 - Performance Standards for Light-Emitting Products, Specific purpose laser products. The device has been tested for conformance to IEC 60601-1 Ed.3.0: 2005 + Corr 1. 2006 + Corr 2. 2007: EN 60601-1 :2006/AC: 2010 Medical electrical equ1pment. Part 1 General requirements for basic safety and essential performance, IEC 60601-1-2 2007, EN 60601-1-2: 2007; EN 60601-1-2 2007/AC 2010 Medical electrical equipment. Part 1-2 General requirements for basic safety and essential performance. Collateral standard: Electromagnetic compatibility -Requirements and tests; IEC 60601-2-22 2007, EN 60601-2-22 2013 Medical electrical equipment - Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment; I EC 60825-1: 2007. EN 60825-1: 2007 Safety of laser products. Part 1: Equipment classification and requirements: IEC 62366: 2007/ A 1 :2014; EN 62366: 2008 Medical devices-Application of usability engineering to medical devices, and with IEC 60601-1-6: 2010: EN 60601-1-6: 2010 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance-Collateral standard: Usability.

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### Summary of Substantial Equivalence:

The submission and predicate device have substantially equivalent technical and performance characteristics including: power level; energy delivered; aiming beam; laser medium; cooling methods; anatomical sites applicable; warnings and contraindications; and for use on the general population. The raw materials and electrical components of the submission and predicate device have a substantially equivalent design and operating controls.

Where there are differences between the submission and the predicate device K150140, a review of the data showed that the differences did not represent new unacceptable risk to the patient of the device. After review of the subject and predicate devices, including technical, performance, and design information as mentioned above, it is concluded that the device in this 510(k) and the predicate device are substantially equivalent.