Picosecond Laser System (Model PS10-A and PS10-B)

K220268 · Beijing Adss Development Co., Ltd. · GEX · Aug 23, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220268
• Device Name: Picosecond Laser System (Model PS10-A and PS10-B)
• Applicant: Beijing Adss Development Co., Ltd.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Aug 23, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength: - Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV. 532nm wavelength: - Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange. - Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

Device Story

Picosecond Laser System is a multi-wavelength, pulsed Nd:YAG laser for surgical and aesthetic dermatology. Device comprises a host unit, articulated arm with treatment handpiece, light guide system, and foot switch. Operator (physician) selects parameters via LCD touch screen. Device delivers 1064nm or 532nm laser pulses to target tissue; energy is absorbed by tattoo pigments or pigmented lesions, facilitating removal or treatment. System includes internal water-to-air heat exchanger for cooling. Used in clinical settings; provides non-invasive treatment for skin conditions. Benefits include precise pigment targeting and lesion clearance.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and compliance with international safety and performance standards.

Technological Characteristics

Nd:YAG laser; 1064nm/532nm wavelengths; 500ps pulse duration; 1-10Hz repetition rate; 2-10mm spot size. Articulated arm beam delivery. Internal water-to-air heat exchanger. LCD touch screen interface. Electrical: 230V, 50Hz. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for tattoo removal (1064nm: Fitzpatrick I-VI, black/brown/green/blue/purple; 532nm: Fitzpatrick I-III, red/yellow/orange) and treatment of benign pigmented lesions (Fitzpatrick I-IV).

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

• PicoSecond Nd: YAG Laser System (K200116)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Beijing ADSS Development Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801, No.161, East Lujiazui Rd., Pudong Shanghai, Shanghai 200120 China

August 23, 2022

Re: K220268

Trade/Device Name: Picosecond Laser 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: July 12, 2022 Received: July 22, 2022

Dear Boyle 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 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

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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 (OS) 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 mediation-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 (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely,

Neil R.P. Ogden Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K220268

Device Name Picosecond Laser System

Indications for Use (Describe)

The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows:

1064nm wavelength:

- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

| 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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## 510(k) Summary

### K220268

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

#### 1.0 submitter's Information

| Name: | Beijing ADSS Development Co., Ltd. |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant address: | F2,Building 1,Jinyuan Road 36 Daxing Economic Development<br>Zone, 102628 Beijing, PEOPLE'S REPUBLIC OF CHINA |
| Production address: | Fuda Road - Tongsheng Road, Southern Area of Industrial<br>Park,Gu'an County, 065599 Langfang City, Hebei Province,<br>PEOPLE'S REPUBLIC OF CHINA |
| Tel: | 86-13051615111 |
| Contact: | Song Ying |

### Designated Submission Correspondent

| Contact: | Mr. Boyle Wang |
|----------|------------------------------------------------------------------------|
| Name: | Shanghai Truthful Information Technology Co., Ltd. |
| Address: | Room 1801, No. 161 East Lujiazui Rd., Pudong Shanghai,<br>200120 China |
| Tel: | [phone] |
| Email: | [e-mail] |

Date of Preparation: Jul.12th,2022

#### 2.0 Device Information

| Trade name: | Picosecond Laser System |
|----------------------|----------------------------------------------------------------------------------------|
| Common name: | Powered Laser Surgical Instrument |
| Classification name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Model(s): | PS10-A, PS10-B |
| Production code: | GEX |
| Regulation number: | 21CFR 878.4810 |
| Classification: | Class II |
| Panel: | General & Plastic Surgery |

#### 3.0 Predicate Device

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K220268

Manufacturer: Shanghai Apolo Medical Technology Co., Ltd. Trade/Device Name: PicoSecond Nd: YAG Laser System 510(k) number: K200116

#### 4.0 Device Description

The Picosecond Laser System consists of a host, a treatment handpiece, a light guide system, a foot switch, power cords and accessories. The host contains a laser, a cooling device, a laser power supply, a control device (including a control device and a LCD) and a protective device. Accessories include a foot switch, a laser protective qlasses, power cords, and a water filling device.

The Picosecond Laser System is a multi-wavelength, pulsed laser system. A key feature of the device is its ability to produce two laser wavelengths (i.e., 1064 nm and 532 nm).

#### 5.0 Indication for Use Statement

The Picosecond Laser System is intended for use in surgical and aesthetic application in the medical dermatology and general and plastic surgery as follows: 1064nm wavelength:

- Removal of tattoos on all skin type (Fitzpatrick skin types I-VI) with the following tattoo colors: black, brown, green, blue and purple.

- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

532nm wavelength:

- Removal of tattoos on Fitzpatrick skin types I-III with the following tattoo colors: red, yellow and orange.

- Treatment of benign pigmented lesions on Fitzpatrick skin types I-IV.

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#### 510(k) Summary

# K220268

### 6.0 Comparison to the Predicate Device

| Item | Subject device | Predicate device 1(Primary)<br>K200116 |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade/Device<br>Name | Picosecond Laser System | PicoSecond Nd: YAG Laser<br>System |
| Manufacturer | Beijing ADSS Development<br>Co., Ltd. | Shanghai Apolo Medical<br>Technology Co., Ltd. |
| Class &Code | Class II<br>GEX 878.4810 | Class II<br>GEX 878.4810 |
| Intended<br>Use/Indication<br>for Use | The Picosecond Laser<br>System is intended for use<br>in surgical and aesthetic<br>application in the medical<br>dermatology and general<br>and plastic surgery as<br>follows:<br>1064nm wavelength:<br>- Removal of tattoos on all<br>skin type (Fitzpatrick skin<br>types I-VI) with the following<br>tattoo colors: black, brown,<br>green,blue and purple.<br>- Treatment of benign<br>pigmented lesions on<br>Fitzpatrick skin types I-IV.<br>532nm wavelength:<br>- Removal of tattoos on | The PicoSecond Nd: YAG Laser<br>System is intended for use in<br>surgical and aesthetic<br>application in the medical<br>dermatology and general and<br>plastic surgery as follows:<br>1064nm wavelength:<br>- Removal of tattoos on all skin<br>type (Fitzpatrick skin types I-VI)<br>with the following<br>tattoo colors: black, brown,<br>green, blue and purple.<br>- Treatment of benign pigmented<br>lesions on Fitzpatrick skin types<br>I-IV.<br>532nm wavelength:<br>- Removal of tattoos<br>on<br>Fitzpatrick skin types I-III with |
| | Fitzpatrick skin types I-III<br>with the following tattoo<br>colors: red, yellow and<br>orange.<br>- Treatment of benign<br>pigmented lesions on<br>Fitzpatrick skin types I-IV. | the following tattoo colors:<br>red, yellow and orange.<br>- Treatment of benign pigmented<br>lesions on Fitzpatrick skin types<br>I-IV. |
| Type of Use | Prescription Use | Prescription Use |
| Wavelength | 1064/532 nm | 1064/532 nm |
| Pulse Duration<br>(Pulse Width) | 500ps | 300 – 500 ps |
| Pulse Energy | 500mJ(1064nm)<br>250mJ (532nm) | 500mJ(1064nm)<br>250mJ (532 nm) |
| Peak Power<br>(Gigawatts) | 1.0 | Not Publicly Available |
| Aiming Beam | 635nm | Not Publicly Available |
| Repetition<br>Rate | 1~10Hz | Single, 1, 2, 3, 4, 5,<br>6, 7, 8, 9, 10 Hz |
| Spot size | 2mm-10mm | Adjustable spot size<br>2~10mm |
| Maximum<br>Average<br>Fluence<br>( J/cm²) | 1064 nm: 15.5 J/cm²<br>532 nm: 8 J/cm² | Not Publicly Available |
| Laser Type | Nd:YAG | Nd:YAG |

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510(k) Summary

# K220268

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# K220268

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# K220268

| Activation | foot-switch | foot-switch |
|-------------------------|-----------------------------------------|--------------------------------|
| Display | LCD Touch screen | LCD Touch screen |
| Cooling<br>System | Internal water to air heat<br>exchanger | Cooling System |
| Electrical<br>Power | AC 230V, 50Hz | 120VAC 10A,<br>50/60Hz |
| Beam Delivery<br>System | Articulated Arm with<br>Handpiece | Articulated Arm with Handpiece |
| System<br>dimension | 93cm × 40 cm × 93 cm | 97cm H x 48cm W x 97cm D |
| System Weight<br>(kg) | 128 kg | 130kg |

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Analysis:

From the comparison table, the subject device and predicate device have the same Intended use & Indications for Use, and comparable technological parameters,

#### 7.0 Non-Clinical Tests

Non clinical tests were conducted to verify that the subject 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:

- 60601-1: 2005+corr.1:2006+Corr.2.2007+A1:2012 Medical IEC Electrical Equipment -- Part 1: General Requirements for Basic Safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- 60601-2-22:2012, Medical electrical equipment - IEC Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
- IEC 60825-1:2014 Safety of Laser products-Part 1: Equipment classification and Requirements
- ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- Software Information: Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Bench Testing: Bench testing was performed to make sure that the device delivers set energy parameters within specifications.

#### 8.0 Clinical Test Conclusion

No clinical study is included in this submission.

#### 9.0 Conclusion

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