K Number
K232575
Device Name
Hair Removal Device, Model(s): R2815-G Pro, R2815-G
Date Cleared
2023-11-20

(87 days)

Product Code
Regulation Number
878.4810
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.
Device Description
Hair Removal Device (Model: R2815-G Pro, R2815-G), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain. The Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface. The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by finger switch.
More Information

Not Found

No
The summary does not mention AI or ML, and the device description focuses on basic IPL technology and a skin sensor for contact detection.

No.
The device is intended for cosmetic hair removal and not for treating or diagnosing a medical condition.

No
The device is described as a "Hair Removal Device" intended for "removal of unwanted body hair and/or facial hair" and for "hair reduction." Its function is to reduce hair growth using Intense Pulsed Light (IPL), not to diagnose any medical condition.

No

The device description clearly outlines physical hardware components (IPL light source, skin sensor, treatment window, power adapter, finger switch) and mentions electrical safety and EMC testing, indicating it is a hardware device with embedded software, not a software-only medical device.

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
  • Device Function: The Hair Removal Device uses Intense Pulsed Light (IPL) to reduce hair growth on the body and face. It works directly on the skin and does not involve analyzing any biological specimens.
  • Intended Use: The intended use is for "removal of unwanted body hair and/or facial hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.

The description clearly indicates it's a device that interacts with the body's surface for a physical effect (hair reduction), not a device that analyzes biological samples for diagnostic information.

N/A

Intended Use / Indications for Use

Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

Product codes

OHT

Device Description

Hair Removal Device (Model: R2815-G Pro, R2815-G), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface.

The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by finger switch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Body, facial

Indicated Patient Age Range

Not Found

Intended User / Care Setting

home-use and personal device

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

  1. Biocompatibility Testing: The biocompatibility evaluation for the body-contacting components of the Hair Removal Device was conducted 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 September 4, 2020'', as recognized by FDA. The following testing was performed to, and passed, including:
  • 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 devices Part 23: Tests for irritation
  1. Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, as per the following standards:
  • IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
  • IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
  • IEC 60601-1-11 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 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
  1. Eye Safety:
  • IEC 62471 Photobiological safety of lamps and lamp systems
  1. 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.

  2. Usability: The product usability has been evaluated according to the following FDA guidance: > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016

Summary: Based on the above performance as documented in this application, the Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate devices.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K223928, K231613

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
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.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.

0

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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 20, 2023

Shenzhen Jianchao Intelligent Technology Co., Ltd. % Riley Chen Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China

Re: K232575

Trade/Device Name: Hair Removal Device, Model(s): R2815-G Pro, R2815-G 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: August 25, 2023 Received: August 25, 2023

Dear Riley Chen:

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 (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 available 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.

1

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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product: and 21 CFR 820.100. Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn).

2

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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Tanisha L. Hithe Tanisha L.J 2023.11.20 Hithe -S 14:28:35 -05'00' Tanisha Hithe 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

3

Indications for Use

510(k) Number (if known) K232575

Device Name Hair Removal Device Model(s): R2815-G Pro, R2815-G

Indications for Use (Describe)

Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial 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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4

510(k) Summary - K232575

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

I. Submitter

Shenzhen Jianchao Intelligent Technology Co., Ltd. Rm301, Bldg.25, No.68 Hexiu West Road, Fuhai St., Baoan, Shenzhen, CN Post code: 518107 Fax: +86-0755-86961489

Fred Li Title: Director Tel.: +86 18675507170 Email: fred@vellcolife.com

II. Device

Name of Device: Hair Removal Device Model(s): R2815-G Pro, R2815-G Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation 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:

ManufacturerPredicate Device510(k) NumberApproval Date
Shenzhen Fansizhe Science
and Technology Co., LtdIntense Pulsed Light (IPL)
System, model: T023K, T023A,
T023B, T023C, T023D, T023E,
T021K, T021A, T001A, T001B,
T001M, T001N, T011C, T016KK223928Mar. 28, 2023

Secondary predicate device:

ManufacturerPredicate Device510(k) NumberApproval Date
Zhuzhou
Goldenhot
Medical Technology Co.,
Ltd.Intense pulsed light device,
Model(s): DE01A-B, DE01A-G,
DE01B-B, DE01B G, DE01C-
B, DE01C-G, DE02A-B,
DE02A-G, DE02B-B, DE02B-
G, DE02C-B, DE02C-G.K231613Jul. 31, 2023

5

IV. Device Description

Hair Removal Device (Model: R2815-G Pro, R2815-G), is an over-the-counter, home-use and personal device for hair reduction based on Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.

The Hair Removal Device includes two models that are R2815-G Pro, R2815-G, and their indications for use, work principle, product structure and composition, electrical structure, performance and operation are basically the same, the only difference is that the R2815-G Pro is equipped with sapphire while R2815-G is not but with a metal treatment window surface.

The device is only powered by the external power adapter. The device is fitted with a skin sensor to detect appropriate skin contact, if the treatment window of the device is not in full contact with the skin, the device cannot emit light pulses, and the IPL emission activation is by finger switch.

V. Indications for Use

Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair and/or facial hair.

VI. Materials

Component nameMaterial of ComponentBody Contact CategoryContact Duration
Hair Removal Device (Enclosure and treatment window)PC+ABS, Sapphire (Al2O3), Stainless steel 430Surface-contacting device: Intact skinLess than 24 hours

We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to "Biocompatibility Discussion".

VII.Comparison of Technological Characteristics With the Predicate Device

The Hair Removal 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 Hair Removal Device may be found substantially equivalent to its predicate devices.

Hair Removal Device is compared with the following Predicate Devices in terms of intended use, design, specifications and performance:

| Comparison

ElementsSubject DevicePrimary Predicate DeviceSecondary Predicate DeviceRemark
510(k)
NumberPendingK223928K231613/
Comparison
ElementsSubject DevicePrimary Predicate DeviceSecondary Predicate DeviceRemark
Trade nameHair Removal DeviceIntense Pulsed Light (IPL)
SystemIntense pulsed light device/
ModelR2815-G Pro, R2815-GT016KDE01A-B, DE01A-G,
DE01B B, DE01B-G,
DE01C-B, DE01C G,
DE02A-B, DE02A-G,
DE02B B, DE02B-G,
DE02C-B, DE02C-G/
ManufacturerShenzhen
Jianchao
Intelligent
Technology
Co., Ltd.Shenzhen Fansizhe Science
and Technology Co., LtdZhuzhou Goldenhot Medical
Technology Co., Ltd./
Regulation
number21 CFR 878.481021 CFR 878.481021 CFR 878.4810Same
Product codeOHTOHTOHTSame
Device
classificationClass IIClass IIClass IISame
Indication for
use/ Intended
useHair Removal Device is
an over-the-counter
device intended for
removal of unwanted
body hair and/or facial
hair.The Intense Pulsed Light
(IPL) System is an over-
the-counter
device
intended for the removal of
unwanted body hair.The Intense pulsed
light
device is an over-the-counter
device, intended for removal
of unwanted body
and/or
facial hair.Same
Prescription
or OTCOTCOTCOTCSame
Device design
Source
energyAn external
power
supplyAn external power supplyAn external power supplySame
Power supply100~240V, 50/60Hz100~240V, 50/60HzAC 100 ~240V , 50/60 HzSame
Dimension
(mm)19411745mm9044225mm for T016KDE01A-B, DE01A-G:
218(W)x77(H)x97(L)mm
DE01B-B, DE01B-G,
DE01C-B, DE01C-G:
218(W)x77(H)x103(L)mm
DE02A-B, DE02A-G:
178(W)x67(H)x150(L)mm
DE02B-B, DE02B-G,
DE02C-B, DE02C-G:
183(W)x67(H)x150(L)mmDifferent
SterilizationNot requiredNot requiredNot requiredSame
Output specification
Light sourceIntense Pulsed LightIntense Pulsed LightIntense Pulsed LightSame
Comparison
ElementsSubject DevicePrimary Predicate DeviceSecondary Predicate DeviceRemark
Energy
mediumXenon Arc FlashlampXenon Arc FlashlampXenon FlashlampSame
Wavelength
range530-1200nm510~1200nm510~1200nmSimilar
Energy
densityMax. 5.2J/cm²Max. 5.73J/cm² for T016K1.2~4.1J/cm²Similar
Output
energy5~14.5J4.8~18.9J for T016KBody: 6.4-14.0 J
Face: 5.6-11.9 J
Bikini line: 5.7-12.8 JSimilar
Spot size3.4±0.25 cm²3.3 cm² for T016K3.9 cm²Similar
Pulse
duration8.5±2.5ms4~12msBody mode: 7~9 (±2.0) ms
Face mode: 8~10 (±2.0) ms
Bikini mode: 9~11 (±2.0) msSimilar
Pulsing
controlFinger switchFinger switchFinger switchSame
Delivery
deviceDirect illumination to tissueDirect illumination to tissueDirect illumination to tissueSame
Output
intensity level9 levelsUnknown5 levelsDifferent
Software/
Firmware/
Microprocess
or Control?YesYesYesSame
Additional information
Electrical
safetyIEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83ANSI AAMI ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83Same
Eye safetyIEC 62471IEC 62471IEC 62471Same
Biocompatibi
lityISO 10993-5
ISO 10993-10
ISO 10993-23ISO 10993-5
ISO 10993-10ISO 10993-5
ISO 10993-10
ISO 10993-23Same

6

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VIII. Performance Data

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

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological

8

Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020'', as recognized by FDA. The following testing was performed to, and passed, including:

  • ISO 10993-5: 2009, Biological evaluation of medical devices -Par t 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 devices Part 23: Tests for irritation

2) Electrical Safety and EMC

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

  • IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance

  • IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

  • IEC 60601-1-11 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 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.

5) Usability

The product usability has been evaluated according to the following FDA guidance: > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016

Summary

Based on the above performance as documented in this application, the Hair Removal Device was found to have a safety and effectiveness profile that is similar to the predicate devices.

IX. Conclusions

Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.