IPL Hair Removal Device (Model: KCA423)

K210119 · Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd. · ONF · May 21, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210119
• Device Name: IPL Hair Removal Device (Model: KCA423)
• Applicant: Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: May 21, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

Device Story

IPL Hair Removal Device (Model: KCA423) uses intense pulsed light (IPL) to target hair follicles via selective photothermal treatment; intended for permanent reduction of unwanted body and facial hair. Device operated by patient under physician direction following healthcare provider training. Output is light energy pulse; clinical effect is thermal destruction of hair follicle to inhibit regrowth. Used in home or clinical settings. Benefits include long-term hair reduction.

Clinical Evidence

No clinical data provided in the document; substantial equivalence is based on technological characteristics and intended use.

Technological Characteristics

Intense Pulsed Light (IPL) device; selective photothermal treatment principle; handheld form factor; electrical energy source. No specific materials or software algorithm details provided.

Indications for Use

Indicated for adults with Fitzpatrick skin types I-IV for removal of unwanted body and/or facial hair and permanent reduction in hair regrowth via selective photothermal treatment under physician direction.

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.

Submission Summary (Full Text)

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May 21, 2021

Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd % Iris Fung Regulation Manager SGS-CSTC Standards Technical Services Co., Ltd. 198 Kezhu Road, SCIENTECH Park Guangzhou Economic & Technology Development Guangzhou, Guangdong China

Re: K210119

Trade/Device Name: IPL Hair Removal Device (Model: KCA423) 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: April 14, 2021 Received: April 20, 2021

Dear Iris Fung:

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.

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

Sincerelv.

Purva U. Pandya -S

Purva Pandya 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) K210119

Device Name IPL Hair Removal Device (Model: KCA423)

## Indications for Use (Describe)

The IPL Hair Removal Device (Model: KCA423) indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare for the removal of unwanted body and/or facial hair in adults with Fitzpatrick skin types I - IV. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

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

| <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) |
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| <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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