IPL sapphire ice cooling hair remove device

K221635 · Shenzhen Desida Technology Co., Ltd. · OHT · Aug 31, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221635
• Device Name: IPL sapphire ice cooling hair remove device
• Applicant: Shenzhen Desida Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Aug 31, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

Device Story

Personal, light-based hair reduction device; uses Intense Pulsed Light (IPL) technology via Xenon lamp. Input: user-initiated finger switch activation; skin sensor detects contact to enable pulse emission. Operation: device emits light pulses below skin surface to reduce hair growth; sapphire cooling mechanism minimizes pain. Used by consumers in home environment. Output: light pulses for hair reduction. Benefits: non-invasive, minimal pain hair removal.

Clinical Evidence

Bench testing only. No clinical data provided. Evidence includes biocompatibility (ISO 10993-5, ISO 10993-10), electrical safety (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83), and photobiological eye safety (IEC 62471). Software verification and validation confirmed all specifications met and hazards mitigated.

Technological Characteristics

Xenon arc flashlamp; wavelength 640-1200nm; energy density 3.0-5.1 J/cm2; spot size 3.3cm2; pulse duration 16-24ms. Features sapphire cooling. Powered by external adapter. Software level of concern: moderate. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for removal of unwanted body hair in over-the-counter, home-use settings.

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

• Home Use IPL Beauty Device, MS-216B (K210311)
• DUO, IPL-HH380-IT (K161565)
• IPL Home Use Hair Removal Device, D-1198 (K221001)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

August 31, 2022

Shenzhen Desida Technology Co., Ltd. % Rain Yip Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address

Re: K221635

Trade/Device Name: IPL sapphire ice cooling hair remove device 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: May 26, 2022 Received: June 6, 2022

Dear Rain Yip:

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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

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# Indications for Use

510(k) Number (if known) K221635

#### Device Name

IPL sapphire cooling hair remove device, model: LB06

Indications for Use (Describe)

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

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)

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# 510(k) Summary

"510(k) Summary" as required by 21 CFR Part 807.92.

#### Date: 2022-05-26

#### I. Submitter

Shenzhen Desida Technology Co., Ltd.

5th Floor, Building A, Sanmin Industrial Zone, Shilongzai, Shuitian Community, Shiyan Street, Baoan District, Shenzhen City, Guangdong Province, China

Post code: 518109

Tel.: [phone]

Shuangcheng Yuan

RD engineer

Tel: [phone]

Email: [e-mail]

#### II. Device

Name of Device: IPL sapphire cooling hair remove device Model: LB06

Model: LBU6

Common or Usual Name: Light Based Over-The-Counter Hair Removal

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

Regulatory Class: II

Product Code: OHT

Regulation Number: 21 CFR 878.4810

#### III. Predicate Device

Primary predicate device: 510(k) number: K210311 Manufacturer: Shenzhen Mismon Technology Co.,Ltd. Trade name: Home Use IPL Beauty Device, MS-216B Product code: OHT Approval date: 07/23/2021 Predicate device II: 510(k) number: K161565 Manufacturer: STETIC MEDICAL AESTHETICS DEVELOPMENT (SHENZHEN) CO. ,LTD Trade name: DUO, IPL-HH380-IT Product code: OHT, ONF Approval date: 09/01/2016 Predicate device III:

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510(k) number: K221001 Manufacturer: Shenzhen Beauty Every Moment Intelligent Electric Co.,Ltd. Trade name: IPL Home Use Hair Removal Device, D-1198 Product code: OHT Approval date: 05/12/2022

## IV. Device Description

The IPL sapphire cooling hair remove 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 Intense Pulsed Light (IPL) technology, and it works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The device is only powered by the external adapter and its IPL emission is by finger switch. The device contains a Xenon lamp and a skin sensor to detect appropriate skin contact. If the device is not in full contact with the skin, the device cannot emit the light pulse.

## V. Indications for Use

IPL sapphire cooling hair remove device is an over-the-counter device intended for removal of unwanted body hair.

## VI. Comparison of Technological Characteristics With the Predicate Device

The subject device IPL sapphire cooling hair remove device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the subject device may be found substantially equivalent to its predicate devices.

The subject device is compared with the following Predicate Devices in terms of intended use, design, specifications, and performance:

| Comparison<br>Elements | Subject Device | Primary predicate<br>device K210311 | Predicate device<br>II K161565 | Predicate device<br>III K221001 |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Pending | K210311 | K161565 | K221001 |
| Trade name | IPL sapphire hair<br>cooling remove device<br>/LB06 | Home Use IPL<br>Beauty Device/MS-<br>216B | DUO/IPL-<br>HH380-IT | IPL Home Use<br>Hair Removal<br>Device/D-1198 |
| Wavelength<br>range | 640-1200nm | 510-1100nm | 480-1200nm | 530-1100nm |
| Energy medium | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp | Xenon Arc<br>Flashlamp |
| Energy density | $3.0~5.1J/cm^2$ | $2.5~4.5J/cm^2$ | $5J/cm^2$ Max. | $2.0~4.3J/cm^2$ |
| Spot size | 3.3cm2 | 3.0cm2 | 3.0cm2 | 2.7cm2 |
| Pulse duration | 16~24ms | 9~12ms | <20ms | 5~12ms |
| Comparison<br>Elements | Subject Device | Primary predicate<br>device K210311 | Predicate device<br>II K161565 | Predicate device<br>III K221001 |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch |
| Delivery device | Direct illumination<br>to tissue | Direct illumination to<br>tissue | Direct<br>illumination to<br>tissue | Direct<br>illumination to<br>tissue |
| Indication<br>for<br>use/Intended use | IPL<br>sapphire<br>cooling<br>hair<br>remove device is<br>an<br>over-the-<br>counter<br>device<br>intended<br>for<br>removal<br>of<br>unwanted<br>body<br>hair. | The Home Use IPL<br>Beauty Device is an<br>over-the-counter<br>device intended for<br>removal of unwanted<br>hair such as but not<br>limited to small areas<br>such as underarm<br>and facial hair below<br>the chin line and<br>large areas such as<br>legs. | The<br>DUO<br>(Model:<br>IPL-<br>HH380-IT) is an<br>over the Counter<br>device intended<br>for the removal of<br>unwanted body<br>and/or facial hair<br>in adults.<br>The<br>DUO is also<br>intended for<br>permanent<br>reduction in<br>unwanted hair.<br>Permanent hair<br>reduction is<br>defined as the<br>long-term stable<br>reduction in the<br>number of hairs<br>regrowing when<br>measured at 6. 9.<br>and 12 months<br>after the<br>completion of a<br>treatment<br>regimen. | IPL Home Use<br>Hair Removal<br>Device is an over-<br>the-counter<br>device intended<br>for removal of<br>unwanted body<br>and/or facial hair. |
| Location for use | OTC | OTC | OTC | OTC |

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#### VII.Performance Data

The following performance data were provided in support of the substantial equivalence determination.

#### 1) Biocompatibility Safety

The materials of the patient-directly contacting components of the subject device is performed the biocompatibility evaluation in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document issued on Sep. 4, 2020", as recognized by FDA. The battery of testing was performed to, and passed, including:

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- > ISO 10993-5 Biological Evaluation of Medical Devices –Part 5: Tests for In Vitro Cytotoxicity
- > ISO 10993-10 Biological Evaluation of Medical Devices –Part 10: Tests for Irritation and Skin Sensitization

# 2) Electrical Safety

Electrical safety and Eye safety testing was performed to, and passed, the following standards:

- > IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- > IEC 60601-1 Medical electrical equipment -Part 1: General requirements for basic safety and essential performance
- > IEC 60601-1-11 Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment
- > IEC 60601-2-83 Medical Electrical Equipment Part 2-83: Particular Requirements For The Basic Safety And Essential Performance Of Home Light Therapy Equipment

## 3) Eye Safety

- > IEC 62471 Photobiological safety of lamps and lamp systems
#### 4) Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. Summary

Based on the above performance as documented in this application, the subject device IPL sapphire cooling hair remove device was found to have a safety and effectiveness profile that is similar to the predicate device.

#### VIII. Conclusions

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the comparison of intended use, design, materials and performance, the subject device IPL sapphire cooling hair remove device is to be concluded substantial equivalent to its predicate device.