Multi-modality workstation

K192519 · Beijing Superlaser Technology Co., Ltd. · ONF · Nov 27, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192519
• Device Name: Multi-modality workstation
• Applicant: Beijing Superlaser Technology Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Nov 27, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Story

Multi-modality workstation is an intense pulsed light (IPL) system; delivers pulsed-light energy via handpiece to target chromophores. Operates on principle of selective thermolysis; pulse width limited below thermal relaxation time of skin to spare normal tissue while damaging targets. Used in clinical settings by trained professionals for surgical and aesthetic applications. Device produces light pulses at wavelengths ranging from 520nm to 1200nm; energy density 1-50J/cm2; pulse width 1-25ms. Healthcare providers use device to treat hair, pigmented lesions, and vascular lesions; output affects clinical decision-making by enabling targeted thermal destruction of specific chromophores. Benefits include permanent hair reduction and lesion clearance.

Clinical Evidence

Bench testing only. No clinical data included.

Technological Characteristics

IPL system; sapphire delivery system; energy 1-50J/cm2; pulse width 1-25ms. Materials: Handpiece components tested for biocompatibility per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation/sensitization). Standards: IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-57 (non-laser light source safety), IEC 62471 (photobiological safety).

Indications for Use

Indicated for patients requiring permanent hair removal, reduction of benign pigmented lesions, or reduction of benign vascular lesions.

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

• IPL Therapy Machine (K161286)

Submission Summary (Full Text)

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November 27, 2019

Beijing Superlaser Technology Co., Ltd. % Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District BeiJing, 102401 CN

Re: K192519

Trade/Device Name: Multi-modality workstation, Model: AAD Dual Light 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: ONF Dated: September 9, 2019 Received: September 13, 2019

Dear Ray 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K192519

Device Name

Multi-modality workstation, Model: AAD Dual Light

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

Indications for Use (Describe)

The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

| <div> <span> <span style="padding-right: 10px;"> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> </div> |
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# 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: K192519

- 1. Date of Preparation: 11/27/2019
- 2. Sponsor Identification

## Beijing Superlaser Technology Co., Ltd.

No.2 Zhongfu Street, Economic and Technological Industrial Zone, Xihongmen Town, Daxing District, Beijing, 100076, China

Contact Person: Shi Shuang Position: Registration Specialist Tel: [phone] ext. 806 Fax: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

## Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, BeiJing, China 102401

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

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#### 4. Identification of Proposed Device

Trade Name: Multi-modality workstation

Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): AAD Dual Light

Regulatory Information:

Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology; Classification: II;

Product Code: ONF;

Regulation Number: 21 CFR 878.4810;

Review Panel: General & Plastic Surgery;

### Indication For Use Statement:

The Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

### Device Description:

The Multi-modality workstation is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 520mm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL Systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

Based on this, the Multi-modality workstation (inclusive of the handpiece used to deliver pulsed-light energy) is indicated for use in surgical and aesthetic applications in permanent hair removal, and reduction of benign pigmented lesions and benign vascular lesions.

#### 5. Identification of Predicate Device(s)

510(k) Number: K161286 Predicate Device Name: IPL Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd

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#### 6. Non-Clinical Test Conclusion

Non-clinical tests were conducted to verify that the proposed device met all design specifications to support that it is Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device conforms to the following standards:

a) IEC60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

b) AAMI/ANSI/ES 60601-1:2005/A1:2012, Medical equipment - Part 1: General requirements for basic safety and essential performance

c) IEC60601-2-57:2011, Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

d) IEC 62471 First edition 2006-07, Photobiological safety of lamps and lamp systems

e) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity. f) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.

- Clinical Test Conclusion 7.
No clinical study is included in this submission.

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### Substantially Equivalent (SE) Comparison 8.

| ITEM | Proposed Device | Predicate Device<br>IPL Therapy Machine VE2000<br>(K161286) | Remark |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Code | ONF | ONF | SAME |
| Regulation<br>No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SAME |
| Class | II | II | SAME |
| Intended Use | The Multi-modality<br>workstation (inclusive of the<br>handpiece used to deliver<br>pulsed-light energy) is indicated for<br>use in surgical and aesthetic<br>applications in permanent hair<br>removal, reduction of benign<br>pigmented lesions and benign<br>vascular lesions.<br>Permanent hair reduction is defined<br>as the long-term, stable reduction in<br>the number of hairs regrowing when<br>measured at 6, 9, and 12 months<br>after the completion of a treatment<br>regimen. | The VE2000 device is indicated<br>for use in surgical, aesthetic<br>applications in permanent hair<br>reduction, reduction of benign<br>pigmented lesions and benign<br>vascular lesions.<br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of hairs<br>regrowing when measured at 6, 9,<br>and 12 months after the<br>completion of a treatment<br>regimen. | SAME |

| Table 9-1 General Comparison |
|------------------------------|
|------------------------------|

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| ITEM | Proposed Device | Predicate Device<br>IPL Therapy Machine VE2000<br>Systems(K161286) | Remark |
|----------------|--------------------------------------------------------------|--------------------------------------------------------------------|------------|
| Light source | Intense pulsed light | Intense pulsed light | SAME |
| Wavelength | 520-650;<br>800~1200;<br>540-800;<br>640-1200; | 480nm-1200nm<br>590nm-1200nm<br>640nm-1200nm | Analysis 1 |
| Deliver system | Sapphire | Sapphire | SAME |
| Energy density | 1-50J/cm2 | 1-50J/cm2 | SAME |
| Pulse Width | 1-25ms | 1-25ms | SAME |
| Max. Power | 3500VA | 2200W | Analysis 5 |
| Spot size | Small: 40 x 12 mm<br>Large: 46 x 16mm<br>Ex-Large: 60 x 20mm | 12x30mm | Analysis 1 |

## Table 9-2 Performance Comparison

Table 9-3 Setting Comparison of Specified Indication for Use

| ITEM | Proposed Device | Predicate Device<br>IPL Therapy Machine VE2000<br>(K161286) | Remark |
|--------------------------|--------------------------------------------------------------|-------------------------------------------------------------|------------|
| hair removal | | | |
| Wavelength Range<br>(nm) | 640-1200 | 640-1200 | SAME |
| Energy Range<br>(J/cm2) | 5 to 40 | 10-44 | SIMILAR |
| Pulse Width (ms) | 1-25 | 3-14 | Analysis 3 |
| Spot Size (mm) | Small: 40 x 12 mm<br>Large: 46 x 16mm<br>Ex-Large: 60 x 20mm | 12x30mm | Analysis 4 |
| pigmented lesions | | | |
| Wavelength Range<br>(nm) | 540-800 | 480-1200 | Analysis 1 |
| Energy Range<br>(J/cm2) | 1-30 | 12-44 | Analysis 2 |
| Pulse Width (ms) | 1-20 | 3-9 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |
| vascular lesions | | | |
| Wavelength Range<br>(nm) | 520-650;<br>800-1200 | 590-1200 | Analysis 1 |
| Energy Range<br>(J/cm2) | 5-30 | 10-42 | Analysis 2 |

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| (J/cm2) | | | |
|------------------|------------|---------|------------|
| Pulse Width (ms) | 1-15 | 3-8 | Analysis 3 |
| Spot Size (mm) | 40 x 12 mm | 12x30mm | Analysis 4 |

## Difference Analysis:

## #1: Wavelength

The wavelength range of proposed devices is very closed to that of predicate devices. The slight difference is considered to have no negative effect on effectiveness and safety, and the bench tests conducted on the proposed device support substantial equivalence to the predicate device.

## #2: Energy Range

The proposed device has an energy output range that is similar to the predicate device, and the slight differences do not result in negative safety and efficacy effects. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.

## #3: Pulse Width

The proposed device has a similar pulse width range as the predicate device. The slight difference in settings do not result in negative safety and effectiveness. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.

## #4: Spot Size

The proposed device has different spot size with the predicate device. However the differences in spot sizes are not considered to produce a negative effect on safety. The bench tests conducted on the proposed device support substantial equivalence to the predicate device.

## #5 Max Power

The maximum input power of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility

| ITEM | Proposed Device | Predicate Device<br>IPL Therapy Machine VE2000<br>(K161286) | Remark |
|----------------------|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|------------|
| | | | |
| | | | |
| Power supply | 110V, 60Hz or 230V, 50Hz | 110V 50Hz | Analysis 6 |
| Electrical<br>Safety | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1 | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1 | SE |
| EMC | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1-2 | The proposed devices were<br>tested to demonstrated to<br>comply with IEC 60601-1-2 | SE |

### Table 9-4 Safety Comparison

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| Patient Contact<br>Material | Handpiece | Handpiece | SE |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|----|
| Biocompatibility | | | |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not induce irritation to skin. (ISO 10993-10) | Applied sample did not induce irritation to skin. (ISO 10993-10) | SE |
| Sensitization | The test article showed no signification evidence of causing skin sensitization in the guinea pig .(ISO 10993-10) | The test article showed no signification evidence of causing skin sensitization in the guinea pig .(ISO 10993-10) | SE |

## #6 Power Supply

The power supply of the proposed device is different from the predicate device. However, the proposed device conforms to IEC 60601-1 and IEC 60601-1-2 regarding device safety and electromagnetic compatibility.

#### 9. 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.