(59 days)
No
The description mentions a "skin color recognition function," but there is no indication that this function utilizes AI or ML. The document lacks any mention of AI, ML, training data, or performance metrics typically associated with AI/ML systems.
No
The device is intended for removal of unwanted body and/or facial hair, which is a cosmetic purpose rather than a therapeutic one for a disease or condition.
No
Explanation: The device is intended for hair removal, which is a treatment or cosmetic procedure, not a diagnostic one. Diagnostic devices are used to identify or detect medical conditions or diseases.
No
The device description explicitly details hardware components such as the main body, power adapter, non-removable lamp head (Xenon flashlamp), and variations in physical features like size, appearance, and enclosure color. It is a physical device utilizing IPL technology.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body and/or facial hair." This is a cosmetic or therapeutic purpose, not a diagnostic one. IVD devices are used to examine specimens (like blood, urine, or tissue) from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
- Device Description: The device uses Intense Pulsed Light (IPL) technology to target hair follicles. This is a physical interaction with the body, not an analysis of a biological sample.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information.
Therefore, this device falls under the category of a light-based device for hair reduction, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body and/or facial hair
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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.
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL 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:
- A 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 skin irritation
- Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- A IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- A ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- A IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A 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
- Eye Safety
- A IEC 62471 Photobiological safety of lamps and lamp systems
-
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. -
Usability
The product usability has been evaluated and verified according to the following FDA guidance Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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 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 features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 31, 2023
Zhuzhou Goldenhot Medical Technology Co., Ltd. % Candice Qui Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K231613
Trade/Device Name: 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. 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: June 1, 2023 Received: June 2, 2023
Dear Candice Qui:
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
1
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 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 (1-800-638-2041 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) K231613
Device Name
Intense pulsed light device Model(s): DE01A-B, DE01A-G, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02B-G, DE02C-B, DE02C-G
Indications for Use (Describe)
The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial harr.
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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3
510(k) Summary - K231613
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Zhuzhou Goldenhot Medical Technology Co.,Ltd.
Room 301, Plant C-3, Phase 5, Xinma Power Innovation Park, No. 889, Xianyue huan Road, Majiahe Street,Tianyuan District, Zhuzhou City, Hunan Province, China Post code: 412007 Tel.: +86 0731 28589339 Liu Xianwu Deputy Manager Tel: +86 13808497058 Email: 2850977367@qq.com
II. Device
Name of Device: 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 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 and Reference Device
Predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Fansizhe Science | |||
| And Technology Co., Ltd | Intense Pulsed Light (IPL) System | ||
| (T023K, T023A, T023B, | |||
| T023C, T023D, T023E, | |||
| T021K, T021A, T001A, | |||
| T001B, T001M, T001N, | |||
| T011C, T016K) | K223928 | March 28, 2023 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| Junbobeauty | |||
| Technology Co., Ltd | IPL HAIR REMOVAL | ||
| HANDSET (IPL-666) | K220669 | May 16, 2022 |
4
IV. Device Description
The Intense pulsed light device is a personal, light-based, hair reduction device. The device provides hair reduction using IPL technology. Of which, the Device includes DE01A-B, DE01A-G, DE01B-B, DE01B-G, DE01C-B, DE01C-G, DE02A-B, DE02A-G, DE02B-B, DE02B-G, DE02C-B, DE02C-G twelve models. All have adopted the same structure design, consisting of Intense pulsed light device main body and power adapter two parts, and one non-removable lamp head (light-emitting treatment window) located in the main body which is the source of optical radiation, namely a Xenon flashlamp. Meanwhile, the device is powered from power adapter via an external power. The difference of all models is mainly product size, appearance, sapphire, skin color recognition function and enclosure color, DE01A series means without sapphire and skin color recognition function. DE01B series means with sapphire, but without skin color recognition function. DE01C series means with sapphire and skin color recognition function. DE02A series means without sapphire and skin color recognition function. DE02B series means with sapphire, but without skin color recognition function. DE02C series means with sapphire and skin color recognition function. Letter -B the enclosure color is blue, letter -G is green, which do not affect the intended use.
V. Indications for Use
The Intense pulsed light device is an over-the-counter device, intended for removal of unwanted body and/or facial hair.
VI. Materials
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| Intense pulsed | |||
| light device | |||
| (Enclosure) | ABS, PC, POM | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".
VII.Comparison of Technological Characteristics With the Predicate Device
The Intense pulsed light device has the same intended use, mode of action and similar operational characteristics as the predicate device. Any minor differences between the subject device and the listed predicate device and reference device do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference device for its intended use. Therefore, the Intense pulsed light device may be found substantially equivalent to its predicate device and reference device.
5
Intense pulsed light device is compared with the following Predicate Device and Reference Device in terms of intended use, design, material, specifications, and performance:
| Comparison
| Elements | Subject Device | Predicate Device | Reference Device | Remark |
|---|---|---|---|---|
| 510(k) | ||||
| Number | Pending | K223928 | K220669 | / |
| Trade name | Intense pulsed light | |||
| device | ||||
| Model: DE01A-B, | ||||
| DE01A-G, DE01B- | ||||
| B, DE01B-G, | ||||
| DE01C-B, DE01C- | ||||
| G, DE02A-B, | ||||
| DE02A-G, DE02B- | ||||
| B, DE02B-G, | ||||
| DE02C-B, DE02C- | ||||
| G | Intense Pulsed Light | |||
| (IPL) System | ||||
| Model: T023K, | ||||
| T023A, T023B, | ||||
| T023C, T023D, | ||||
| T023E, T021K, | ||||
| T021A, T001A, | ||||
| T001B, T001M, | ||||
| T001N, T011C, | ||||
| T016K | IPL HAIR REMOVAL | |||
| HANDSET | ||||
| Model: IPL-666 | / | |||
| Manufacturer | Zhuzhou Goldenhot | |||
| Medical | ||||
| Technology | ||||
| Co.,Ltd | Shenzhen | |||
| Fansizhe | ||||
| Science | ||||
| And | ||||
| Technology Co., Ltd | Shenzhen Junbobeauty | |||
| Technology Co., Ltd | / | |||
| Regulation | ||||
| number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | Same |
| Device | ||||
| classification | Class II | Class II | Class II | Same |
| Indication for | ||||
| use/ Intended | ||||
| use | The Intense pulsed | |||
| light device is an | ||||
| over-the-counter | ||||
| device, intended for | ||||
| removal of | ||||
| unwanted body | ||||
| and/or facial hair. | The Intense Pulsed | |||
| Light (IPL) System | ||||
| is an over-the- | ||||
| counter device | ||||
| intended for the | ||||
| removal of unwanted | ||||
| body hair. | IPL HAIR REMOVAL | |||
| HANDSET is an over- | ||||
| the-counter device | ||||
| intended for removal of | ||||
| unwanted body and/or | ||||
| facial hair. | Same | |||
| Prescription | ||||
| or OTC | OTC | OTC | OTC | Same |
| Applicable | ||||
| skin | Fitzpatrick | |||
| Skin | ||||
| Types I-V | Fitzpatrick | |||
| Skin | ||||
| Phototypes I-V | Fitzpatrick skin types I |
- V | Same |
| Comparison
Elements | Subject Device | Predicate Device | Reference Device | Remark |
| Treatment
area | Small areas such as
bikini line.
Large areas such as
arms, legs. | Used on facial hair
below the chin line,
arms, legs,
underarms, bikini
line. | Used on facial hair
below the chin line,
arms, legs, underarms,
bikini line. | Similar |
| Device design | | | | |
| Power source | An external power
supply | An external power
supply | Supplied by external
adapter | Same |
| Power supply | Input: AC 100 ~
240V , 50/60 Hz,
1.0A
Output: 24V==2.5A | Unknown | 100-240V AC Input
12V3A DC Output | Different |
| Dimension | DE01A-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)mm | 116217.842mm
for T023K, T023A,
T023B, T023C,
T023D and T023E
73.281.1202.2mm
for T021K and
T021A
18278151mm for
T001A, T001B,
T001M and T001N
21113860mm for
T011C
9044225mm for
T016K | 124 x83 x 48.5mm | Different |
| Sterilization | Not required | Not required | Not required | Same |
| Output specification | | | | |
| Light source | Intense Pulsed
Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy
medium | Xenon Flashlamp | Xenon
Flashlamp Arc | Xenon Quartz Tube | Similar |
| Wavelength
range | 510-1200nm | 510-1200nm | 470-1100 nm | Similar |
| Energy
density | Body mode: 1.2 ~
4.1 J/cm² | 5.5J/cm2 for T023K, | 1.3-2.49 J/cm² | Similar |
| Comparison
Elements | Subject Device | Predicate Device | Reference Device | Remark |
| | Face mode : 1.2 ~
4.1 J/cm2
Bikini mode: 1.2 ~
4.1 J/cm2 | T023A, T023B,
T023C, T023D and
T023E,
4.8J/cm2 for T021K
and T021A,
4.7J/cm2 for T001A,
T001B, T001M and
T001N,
5.75J/cm2 for
T011C,
5.73J/cm2 for
T016K | | |
| Output energy | Body: 6.4-14.0 J
Face: 5.6-11.9 J
Bikini line: 5.7-
12.8 J | 6.5J ~ 16.6J for
T023K, T023A,
T023B, T023C,
T023D and T023E
5.6J ~ 14.5J for
T021K and T021A
7.3J ~ 18.6J for
T001A, T001B,
T001M and T001N
5.3 J ~ 20.7J for
T011C
4.8J ~ 18.9J for
T016K | Level 1: 3.92J
Level 2: 4.72J
Level 3: 5.62J
Level 4: 6.49J
Level 5: 7.48J | Similar |
| Spot size | 3.9 cm² | 3.0cm² for T023K,
T023A,
T023B,
T023C,
T023D,
T023E, T021K and
T021A,
4.0cm² for T001A,
T001B, T001M and
T001N,
3.6cm² for T011C,
3.3cm² for T016K | 3 cm² | Similar |
| Pulse duration | Body mode:
7.0±2.0 ~ 9.0±2.0
ms
Face mode: 8.0±2.0
~ 10.0±2.0 ms | 4 ~ 12ms | 11.5-15 ms | Similar |
| Comparison
Elements | Subject Device | Predicate Device | Reference Device | Remark |
| | Bikini mode:
$9.0\pm2.0 ~ 11.0\pm2.0$
ms | | | |
| Pulsing
control | Finger switch | Finger switch | Finger switch | Same |
| Delivery
device | Direct illumination to tissue | Direct illumination to tissue | Direct illumination to tissue | Same |
| Output
intensity level | 5 Levels | Unknown | 5 Levels | Same |
| Software/
Firmware/
Microprocess
or Control? | Yes | Yes | Yes | Same |
| Additional features | | | | |
| Electrical
safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-6
IEC 60601-1-11
IEC 60601-2-83 | ANSI AAMI
ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC60601-2-83 | IEC 60601-1,
IEC 60601-1-2
IEC 60601-1-11,
IEC60601-2-83,
IEC 62471 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibil
ity | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
6
7
8
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 IPL 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:
- A 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
9
-
ISO 10993-23:2021, Biological evaluation of medical devices –Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
- A IEC 60601-1-2 Medical electrical equipment –Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
- A ANSI AAMI ES60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
- A IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- A 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
- A 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 and verified according to the following FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Intense pulsed light device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device.