Q-Switched Nd:YAG Laser Therapy Systems

K163123 · Beijing Sincoheren Science and Technology Development Co. · GEX · Feb 2, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163123
• Device Name: Q-Switched Nd:YAG Laser Therapy Systems
• Applicant: Beijing Sincoheren Science and Technology Development Co.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 2, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Q-Switched Nd: Y AG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows: 1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Device Story

Q-switched Nd:YAG laser system (1064nm/532nm) for dermatological procedures; utilizes selective photothermy and blasting mechanism to fragment pigment particles (ink, melanin) for macrophage phagocytosis and lymphatic clearance. System components: laser module, articulated arm, power supply, cooling system, display/control panel. Operated by physicians in clinical settings. Physician selects wavelength, energy, spot size, and fluence via control panel. Output energy targets specific color radicals in dermis/epidermis. Benefits include removal of tattoos and treatment of vascular/pigmented lesions via controlled soft tissue ablation/vaporization.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation per ISO 10993-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing (IEC 60825-1).

Technological Characteristics

Materials: Steel, ABS. Energy: Xenon lamp-pumped Q-switched Nd:YAG/KTP laser. Wavelengths: 1064nm/532nm. Pulse duration: 5ns. Repetition rate: 1-5Hz. Beam delivery: Articulated arm. Cooling: Internal distilled water circulation. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60825-1.

Indications for Use

Indicated for tattoo removal (dark/light inks), benign vascular lesions (port wine stains, telangiectasias, angiomas), and benign pigmented lesions (nevus of ota, cafe-au-lait, lentigines, nevi, freckles) in general dermatology patients.

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

• Nd: YAG Laser System (K133158)

Submission Summary (Full Text)

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Public Health Service

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

February 2, 2017

Beijing Sincoheren Science And Technology Development Co. % Mike Gu Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co.,ltd. 8-9th Floor, R&d Building, No.26 Qinglan St, Panyu District Guangzhou, 510006 CN

Re: K163123

Trade/Device Name: Q-switched Nd:YAG Laser Therapy Systems 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: October 31, 2016 Received: November 8, 2016

Dear Mike Gu:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

# Jennifer R. Stevenson -S

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

#### 510(k) Number (if known) K163123

#### Device Name

O-Switched Nd: YAG Laser Therapy Systems

#### Indications for Use (Describe)

The Q-Switched Nd: Y AG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesion, ablation, vaporization of soft tissue for general dermatology as follows:

1064nm: -Tattoo Removal Dark ink: blue and black. -Treatment of Benign Pigmented Lesions Nevus of ota. 532mm: -Tattoo Removal Light ink: red. Light ink: sky blue and green. - Treatment of Benign Vascular Lesions Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi. -Treatment of Benign Pigmented Lesions Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

Type of Use (Select one or both, as applicable)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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# 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided:

#### SUBMITTER l.

Beijing Sincoheren Science and Technology Development Co., Ltd.

Address: Room 305, No.43, Xizhimen North Street, Haidian District, Beijing, 100044,

China

Phone: [phone]

Fax: [phone]

| Primary Contact Person: | Mike Gu |
|---------------------------|-------------------------------------------------------|
| | Regulatory Affairs Manager |
| | OSMUNDA Medical Device Consulting Co., Ltd |
| | Tel: [phone] |
| | Fax: [phone] |
| Secondary Contact Person: | Huan Kong |
| | Regulatory Affairs Engineer |
| | Beijing Sincoheren Science and Technology Development |
| | Co., Ltd. |
| | Tel: [phone]-8009 |
| | Fax: [phone] |
| Date prepared: | Oct 31, 2016 |

- II. DEVICE

| Name of Device: | Q-Switched Nd: YAG Laser Therapy Systems |
|-----------------------|-----------------------------------------------------|
| Common/Usual Name: | YAG Laser Therapy Systems |
| Classification Names: | Powered Laser Surgical Instrument (21 CFR 878.4810) |
| Regulation Class: | II |
| Product Code: | GEX |

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#### PREDICATE DEVICE III.

Nd: YAG Laser System, K133158

This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

#### IV. DEVICE DESCRIPTION

The Q-Switched Nd:YAG Laser Systems is based on the Q-Switched Nd: YAG (1064 nm) and frequency doubled KTP Nd: YAG (532nm) Laser Technology. There is one optical cavity containing the Nd: YAG Crystal. It is composed of laser module, articulated arm, laser power supply, cooling system and display and control system.

The Q-Switched Nd: YAG Laser Therapy Systems works based on laser selective photothermy and blasting mechanism of Q-switched laser. Energy form particular wavelength with accurate dose will act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanophore from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enters into lymph circulation system and finally be discharged out of body.

The physician is able to select the desired wavelength and the related output energy, spot size and fluency via control panel.

#### V. IDICATIONS FOR USE

The Q-Switched Nd: YAG Laser Therapy System (1064nm or 532nm) is indicated for use in tattoo removal, treatment of benign vascular lesions, treatment of benign pigmented lesions, incision, excision, ablation, vaporization of soft tissue for general dermatology as follows:

#### 1064nm:

-Tattoo Removal

Dark ink: blue and black.

-Treatment of Benign Pigmented Lesions

Nevus of ota.

#### 532nm:

-Tattoo Removal

Light ink: red.

Light ink: sky blue and green.

- Treatment of Benign Vascular Lesions

Port wine birthmarks; Telangiectasias; Spider angioma; Cherry angioma; Spider nevi.

-Treatment of Benign Pigmented Lesions

Cafe-au-lait birthmarks; Solar lentiginos; Senile lentiginos; Becker's nevi; Freckles; Nevus spilus.

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### VI. TECHNOLOGY

The Q-Switched Nd: YAG Laser Therapy Systems works based on the principles of laser selective photothermy and blasting mechanism of Q-switched laser. Energy from particular wavelength with accurate dose act on certain targeted color radicals: ink, carbon particles from derma and epidermis, exogenous pigment particles and endogenous melanocytes from derma and epidermis. When suddenly being heated, pigment particles immediately blast into smaller pieces, which will be swallowed by macrophage phagocytosis and enter into lymph circulation system and finally be discharged out of the body.

| Specification | Predicate device | Proposed device | Discussion of<br>Differences |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| K number | K133158 | -- | |
| Product Code | GEX | GEX | Identical |
| Manufacturer | Beijing Toplaser Technology<br>Co., Ltd | Beijing Sincoheren<br>Science and Technology<br>Development Co., Ltd. | |
| Device name | Nd: YAG Laser System | Q-Switched Nd: YAG<br>Laser Therapy Systems | Similar |
| Indications for use | <b>1064nm:</b><br>-Tattoo Removal<br>◇ Dark ink: blue and black<br>-Treatment of Benign Pigmented Lesions<br>◇ Nevus of ota<br><br><b>532nm:</b><br>-Tattoo Removal<br>◇ Light ink: red<br>◇ Light ink: sky blue and green<br>- Treatment of Benign Vascular Lesions<br>◇ Port wine birthmarks; Telangiectasias; Spider<br>angioma; Cherry angioma; Spider nevi<br>-Treatment of Benign Pigmented Lesions<br>◇ Cafe-au-lait birthmarks; Solar lentiginos; Senile<br>lentiginos; Becker's nevi; Freckles; Nevus spilus.<br>◇ | | Identical |
| Technology | Q-Switched ND:YAG and KTP<br>Nd: YAG Laser | Q -Switched ND:YAG and<br>KTP Nd: YAG Laser | Identical |
| Energy Source | Xenon Lamp | Xenon Lamp | Identical |
| Wavelength (nm) | 1064nm and 532nm | | Identical |
| Aiming beam<br>wavelength | 635nm | | Identical |
| Specification | Predicate device | Proposed device | Discussion of<br>Differences |
| Laser output mode | Q-switched pulse | Q-switched pulse | Identical |
| Aiming laser<br>output power | <5mw | 0.1-5mw | Identical |
| Maximum Pulse<br>Energy | @1064nm wavelength: 1--<br>~1000mJ<br>@532nm wavelength:<br>50-300mJ | @1064nm wavelength:<br>500mJ<br>@532nm wavelength:<br>250mJ | Less than<br>Predicate<br>device , more<br>safe |
| Pulse Duration | 6~8ns | 5ns±1ns or 5ns | Less Pulse<br>Duration, more<br>peak power,<br>more effective |
| Repetition Rate | 1~10Hz | 1-5Hz | Less than<br>Predicate<br>device, more<br>safe |
| Nominal ocular<br>hazard distance | NOHD 2.8km | NOHD 3.3km | Similar |
| Spot Size | Adjustable Spot Size 3-9<br>mm(Diameter) | Adjustable Spot Size 2-10<br>mm(Diameter) | Wider<br>adjustable<br>range of spot<br>size than<br>predicate<br>device, more<br>useful |
| Material | Steel, ABS | Steel, ABS | Identical |
| Beam delivery | Articulating Arm Light Guide | Articulating Arm Light Guide | Identical |
| Cooling | Internal distilled water<br>circulating cooling | Internal distilled water<br>circulating cooling | Identical |
| Anatomical Sites | Skin and subcutaneous<br>tissue | Skin and subcutaneous<br>tissue | Identical |

#### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

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#### VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

#### Biocompatibility testing

The biocompatibility evaluation for the Q-Switched Nd: YAG Laser Therapy Systems was conducted in accordance with the guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:

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- Cytotoxicity
- Sensitization
- Irritation

The handpiece is considered skin and subcutaneous tissue contacting for a duration of less than 24 hours.

# Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Q-Switched Nd: YAG Laser Therapy Systems. The device complies with the IEC 60601-1, standard for safety and the IEC 60601-1-2 standard for EMC.

# Performance testing

Performance testing was conducted on the device according to IEC 60825-1.

# Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

# Animal Study

The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, does not require animal studies to support substantial equivalence.

# Clinical Study

The subject of this premarket submission, Q-Switched Nd: YAG Laser Therapy Systems, did not require clinical studies to support substantial equivalence.

# IX. CONCLUSION

The non-clinical data support the safety of the device and the performance testing report demonstrate that the Q-Switched Nd: YAG Laser Therapy Systems should perform as intended in the specified use conditions. Beijing Sincoheren considers the Q-Switched Nd: YAG Laser Therapy Systems to be substantially equivalent to the predicate device and does not raise any new issues of safety or effectiveness.