Light Based Hair Removal Device GP592

K230060 · Shenzhen Gsd Tech Co., Ltd. · OHT · Mar 3, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230060
• Device Name: Light Based Hair Removal Device GP592
• Applicant: Shenzhen Gsd Tech Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Mar 3, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

Device Story

Personal, over-the-counter light-based hair reduction device; utilizes Intense Pulsed Light (IPL) technology via Xenon flashlamp. Device consists of main body and external power adapter. User operates device via finger switch to deliver direct illumination to skin. Device targets hair follicles for reduction. Intended for home use by consumers. Output is optical radiation; clinical benefit is reduction of unwanted hair.

Clinical Evidence

Bench testing only. Compliance demonstrated with IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare), IEC 60601-1-2 (EMC), IEC 62471 (photobiological safety), IEC 60601-2-83 (light therapy), and ISO 10993 series (biocompatibility: cytotoxicity, skin sensitization, and skin irritation).

Technological Characteristics

Xenon arc flashlamp source; 1.05cm x 2.95cm (3.1cm²) spot size; 4.93 J/cm² max energy density; 1-3ms pulse duration. Powered by external adapter. Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 62471, IEC 60601-2-83, ISO 10993-5, ISO 10993-10, ISO 10993-23.

Indications for Use

Indicated for removal of unwanted hair in small areas (underarm, facial hair below chin line) and large areas (legs) for patients excluding Fitzpatrick Skin Phototypes VI.

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

• Light Based Hair Removal Device (K180383)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows 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.

March 3, 2023

Shenzhen GSD Tech Co., Ltd. Huifang Yao Regulatory Engineer Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District Shenzhen, Guangdong 518106 China

Re: K230060

Trade/Device Name: Light Based Hair Removal Device GP592 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: OHT. Dated: January 9, 2023 Received: January 9, 2023

Dear Huifang Yao:

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.

{1}------------------------------------------------

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.

# Jianting Wang -S

Jianting Wang 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K230060

Device Name Light Based Hair Removal Device GP592

Indications for Use (Describe)

Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

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

| | Prescription Use (Part 21 CFR 801 Subpart D)

|X | 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 PRAStaff(@fda.hhs.gov

"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."

{3}------------------------------------------------

# 510(k) Summary

#### Date Prepared: 2023-01-09

This 510(k) Summary is being submitted in accordance with requirements of Title 21 CFR Section 807.92.

#### 1. Submitter information

Shenzhen GSD Tech Co., Ltd Add .: Building A, JUNSD Hi-Tech Park, West of Bao'An RD. Watch & Clock Base, Guangming District, Shenzhen, China 518106 Establishment Registration Number: 3006580954

Contact Person: Huifang Yao Position: Regulatory Engineer Phone: [phone] E-mail: [e-mail]

#### 2. Device information

Device name: Light Based Hair Removal Device GP592 Trade name: Light Based Hair Removal Device Model number: GP592 Regulation number: 21CFR 878.4810 Regulation name: Light Based Over-The-Counter Hair Removal Regulatory class: II Panel: General & Plastic Surgery Product code: OHT

#### 3. Predicate device information

510(k) Number: K180383 Device Name: Light Based Hair Removal Device Manufacturer: Shenzhen GSD Tech Co., Ltd.

#### 4. Device description

The Light Based Hair Removal Device is a personal, light-based, hair reduction device intended to be sold over-the counter directly to the end user. The device provides hair reduction using IPL technology. The device consists of IPL main body and adapter two parts, and a lamp cap located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from adapter via an external power.

#### 5. Intended use

The Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm

{4}------------------------------------------------

and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI.

| Description | Subject device | Predicate device | Remark |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------|
| 510 (k) number | Pending | K180383 | / |
| Common name | Light Based Over-The-Counter Hair<br>Removal | Light Based Over-The-Counter Hair<br>Removal | Same |
| Trade name/model<br>No. | Light Based Hair Removal Device<br>Model: GP592 | Light Based Hair Removal Device<br>Model: GP586 | / |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Pulse duration | 1~3milliseconds | 2~3milliseconds | Similar |
| Energy density | $4.93J/cm^2$ Max. | $4.2J/cm^2$ Max. | Similar<br>Note 1 |
| Spot size | 1.05cm*2.95cm (3.1cm²) | 1.05cm*2.95cm (3.1cm²) | Same |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue | Same |
| Pulsing control | Finger switch | Finger switch | Same |
| Indication for<br>use/Intended use | Light based hair removal device is an<br>over-the-counter device intended for<br>removal of unwanted hair such as but<br>not limited to small areas such as<br>underarm and facial hair below the<br>chin line and large areas such as legs,<br>excluding patients with Fitzpatrick<br>Skin Phototypes VI. | Light based hair removal device is an<br>over-the-counter device intended for<br>removal of unwanted hair such as but<br>not limited to small areas such as<br>underarm and facial hair below the<br>chin line and large areas such as legs,<br>excluding patients with Fitzpatrick<br>Skin Phototypes VI. | Same |
| Location for use | OTC | OTC | Same |

### 6. Technological characteristics and substantial equivalence:

Note 1: Though the pulse duration and energy density are little different from the predicate device, they comply with the requirements of safety and performance related standards, and the differences are not likely to raise different questions of safety or effectiveness issue or adversely affect patient safety.

#### 7. Nonclinical tests submitted

- . Safety test
IEC 60601-1: 2005+A1: 2012+A2:2020

Medical electrical equipment - Part1: General requirements for basic safety and essential performance

IEC 60601-1-11: 2015

Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare

{5}------------------------------------------------

environment

#### ● EMC test

IEC 60601-1-2: 2020

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances-Requirements and tests

● Reliability test IEC 62471: 2006 Photobiological safety of lamps and lamp systems IEC 60601-2-83: 2019 Medical electrical equipment - Part 2-83: General requirements for basic safety and essential performance of home light therapy equipment

● Biocompatibility test ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity ISO 10993-10: 2021 Biological evaluation of medical devices – Part 10: Tests for skin sensitization ISO 10993-23: 2021 Biological evaluation of medical device — Part 23: Tests for skin irritation

None of the tests demonstrated any design characteristics that may adversely affect patient safety. It is our conclusion that the subject device tested met all relevant requirements of the aforementioned tests.

#### 8. Conclusion

The subject devices have the same intended use and same technological characteristics as the predicate device. Moreover the differences between the subject and predicate don't raise different questions of safety or effectiveness. Thus, the subject device is substantially equivalent to the Predicate Device.