ND YAG Q-switch Laser Therapy Machine

K161926 · Beijing Adss Development Co., Ltd. · GEX · Feb 22, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K161926
• Device Name: ND YAG Q-switch Laser Therapy Machine
• Applicant: Beijing Adss Development Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

Device Story

Nd:YAG Q-switch laser system; delivers 1064nm or 532nm laser energy; used for benign cutaneous/pigmented lesions and tattoo removal. System comprises main unit, articulated arm, treatment probe, and foot pedal. Operated by clinician in clinical setting. Laser energy targets lesions/pigment; Q-switching provides short pulse widths (5-8ns) for photomechanical effect. Clinician uses aiming beam to target treatment area; foot pedal controls pulse output. Output energy 100-1000mJ (1064nm) or 50-500mJ (532nm). Device benefits patients by providing non-invasive removal of tattoos and treatment of skin lesions.

Clinical Evidence

No clinical data. Bench testing only. Compliance verified with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization). Performance testing included spot size accuracy and thermal energy distribution.

Technological Characteristics

Nd:YAG laser; 1064nm/532nm wavelengths; 5-8ns pulse width; 1-10Hz repetition rate. Materials: Stainless steel treatment probe. Energy source: Electrical. Form factor: Floor-standing unit with articulated arm. Safety: Complies with IEC 60601-1, 60601-2-22, 60825-1. Sterilization: Disinfection of handpiece via 75% medicinal alcohol.

Indications for Use

Indicated for treatment of benign cutaneous lesions (warts, scars, striae, psoriasis), benign pigmented lesions (lentigines, nevus, birthmarks), and removal of black or blue tattoos in patients requiring laser therapy.

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

• Harmony XL Multiple Application Platform (K072564)

Reference Devices

• K072536

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

February 22, 2017

Beijing Adss Development Co., Ltd % Mr. Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, Dafangju No. 25 Banbidian Rd. LiYuan Town, Tongzhou District, Beijing, 101121 China

Re: K161926 Trade/Device Name: Nd Yag Q-switch Laser Therapy Machine 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: January 18, 2017 Received: January 23, 2017

Dear Mr. Wang:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

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

510(k) Number (if known) K161926

Device Name ND YAG O-switch Laser Therapy Machine

### Indications for Use (Describe)

The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

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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## Tab #3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K161926

- 1. Date of Preparation
02/16/2017

- Sponsor 2.
## Beijing ADSS Development Co., Ltd

F6, Xiandao Bldg., Jinyuan Rd. 36, Daxing Economic Development zone, Beijing, China, 102628

Establishment Registration Number: Not yet registered or the Number Contact Person: Gao Yurong Position: sales manager Tel: [phone] Fax:[phone] Email: [e-mail]

- Submission Correspondent 3.
Mr. Ray Wang

Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., LiYuan Town, TongZhou District, Beijing, 101121, China

Tel: [phone] Fax: [phone] Email: [e-mail]

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- 4. Identification of Proposed Device
Trade Name: ND YAG Q-switch Laser Therapy Machine Common Name: Powered Laser Surgical Instrument Model(s): FG 2010, FG 2010-B, FG 2010-C

Regulatory Information: Classification Name: Powered Laser Surgical Instrument Classification: II; Product Code: GEX; Regulation Number: 21 CFR 878.4810; Review Panel: General& Plastic Surgery;

Intended Use:

The ND YAG Q-switch Laser Therapy Machine is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.

- 5. Device Description
The ND YAG Q-switch Laser Therapy Machine is laser system which delivers laser at a wavelength 1064nm or 532nm.

There are 3 models included, FG 2010, FG 2010-B, FG 2010-C, the three models have same intended use, mechanism of action, principle and specification, only differences are the configurations. The detailed difference shown as following:

| Model | FG2010 | FG2010-B | FG2010-C |
|--------|---------------|---------------|---------------|
| Size | 860×310×830mm | 800×320×920mm | 830×320×830mm |
| Weight | 60kg | 65kg | 60kg |

Table 1 The Difference of Models

| Table 2 Main Components introduction | | |
|--------------------------------------|--|--|
|--------------------------------------|--|--|

| Component name | Function |
|-----------------|------------------------------------------------|
| Main unit | Main Interface |
| Articulated Arm | Articulated arm for holding of Treatment Probe |
| Treatment Probe | Laser Deliver |
| Foot Pedal | control pulse light output |

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- 6. Identification of Predicate Device
Predicate Device: 510(k) Number K072564

Predicate Device Name Harmony XL Multiple Application Platform

### Manufacturer

Alma Laser, Ltd

- 7. Non-Clinical Test
Non clinical tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- > IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
- > IEC 60601-2-22:2007, Medical Electrical Equipment - Part 2-22: Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
- > IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
- > IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility-Requirements and tests.
- > ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity
- > ISO 10993-10:2002/Amd. 1: 2006, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity AMENDMENT 1
- > Performance Testing for Spot Size Accuracy.
- > Thermal Energy Distribution Test: determine the difference for thermal energy distribution of proposed device with predicate device.
- 8. Clinical Test

No clinical study is included in this submission.

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# 9. Substantially Equivalent (SE) Comparison

| ITEM | Proposed Device | Predicate Device | Remark |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | GEX | GEX | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | 2 | 2 | SE |
| Intended Use | The ND YAG Q-switch Laser Therapy<br>Machine is indicated for the treatment of:<br>benign cutaneous lesions, such as Warts,<br>Scars, Striae and Psoriasis; benign<br>pigmented lesions, such as Lentigines,<br>nevus, and birthmark; and the removal of<br>black or blue tattoos. | The 1064 nm Long Pulsed and Q-switched<br>Nd:YAG Laser Module Handpieces<br>The 1064 nm Nd:YAG Laser Module<br>handpiece (Long Pulsed and Q-switched<br>with and without contact-cooling) are<br>indicated for treatment and clearance of<br>Benign vascular lesions such as, but<br>not limited to treatment of: Port wine stains Hemangiomas Warts Superficial and deep<br>telangiectasias (venulectasias) Reticular veins (0.1-4.0 mm<br>dia.) of the leg Rosacea Venus lake Leg veins Spider veins Angiomas Benign cutaneous lesions, such as,<br>but not limited to : Warts Scars Striae Psoriasis Benign pigmented lesions such as,<br>but not limited to: Lentigos (age spots) Solar lentigos (sun spots) Café-au- lait birthmarks Seborrheic keratoses Nevi and nevus of Ota Chloasma Verrucae | SE |

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| | > Skin tage |
|---|-------------------------------------------|
| | > Keratoses |
| | > The removal of black, blue or |
| | green tattoos (significant |
| | reduction in the intensity of |
| | black and /or blue tattoos) |
| | > Plaques |
| • | Pigmented lesions to reduce lesion |
| | size, for patients with lesions that |
| | would potentially benefit from |
| | aggressive treatment, and for patients |
| | with lesions that have not responded |
| | to other laser treatments. |
| • | The non-ablative treatment of facial |
| | wrinkles, such as, but not limited to: |
| | > Periocular wrinkles |
| | > Perioral wrinkles |
| • | Laser skin resurfacing procedures for |
| | the treatment of: |
| | > Acne scars |
| | > Wrinkles |
| • | Reduction of red pigmentation in |
| | hypertrophic and keloid scars where |
| | vascularity is an integral part of the |
| | scar. |
| | Indicated for use on all skin types |
| | (Fitzpatrick I-VI), including tanned skin |

# Table 4 Performance Comparison

| ITEM | Proposed Device | Predicate Device 2<br>K072536 | Remark |
|---------------------------|---------------------------------------------|-------------------------------|----------|
| Laser Medium | Nd:YAG | Nd:YAG | SE |
| wavelength | 1064 nm<br>532 nm | 1064 nm<br>532 nm | SE |
| Output energy | 100-1000mJ for 1064nm<br>50-500mJ for 532nm | 400-1200mJ | SE |
| Max.<br>Energy<br>Density | 31.8J/cm²<br>15.9 J/cm² | 16.9 J/cm² | SE |
| Spot Size | 2-10mm | 3, 5 mm | Analysis |

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| Pulse Width | 5ns-8ns | 20 ns | Analysis |
|-----------------------------------------------|-----------------------------------------------------------------------------------------|------------|----------|
| Repetition Rate | 1-10 Hz | 1, 2, 4 Hz | Analysis |
| Disinfection | Disinfect the handpiece before and<br>after every treatment by 75%<br>medicinal alcohol | --- | Analysis |
| Laser Class | Class 4 | Class 4 | SE |
| Cooling<br>method<br>for treated skin<br>area | N.A. | N.A. | SE |
| Aiming Beam | Red Laser, < 6mW | N.A | Analysis |

## Table 5 Safety Comparison

| Item | Proposed Device | Predicate Device | Remark |
|------------------------------------------------|--------------------------------------------|--------------------------------------------|--------|
| | | K072536 | |
| Patient Contact Materials and Biocompatibility | | | |
| Patient Contact<br>Materials | Treatment Probe (Stainless Steel) | Treatment Probe (Stainless Steel) | SE |
| Cytotoxicity | No Cytotoxicity | Comply with ISO 10993-1 | |
| Sensitization | No evidence of sensitization | | SE |
| Irritation | No evidence of irritation | | |
| EMC, Electrical and Laser Safety | | | |
| Electrical Safety | Comply with IEC 60601-1, IEC<br>60601-2-22 | Comply with IEC 60601-1, IEC<br>60601-2-22 | SE |
| EMC | Comply with IEC 60601-1-2 | Comply with IEC 60601-1-2 | SE |
| Laser Safety | Comply with IEC 60601-2-22, IEC<br>60825 | Comply with IEC 60601-2-22, IEC 60825 | SE |

## Analysis for difference

The proposed device is substantially equivalent to the predicate device. Based on the nonclinical tests performed, the subject device is as safe, as effective, and performs as well as the legally marketed predicate device.

## 10. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed device is determined to be Substantially Equivalent (SE) to the predicate device.