(84 days)
Not Found
No
The description focuses on standard IPL technology, a skin sensor for contact, and a cooling function. There is no mention of AI/ML terms, data sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an "IPL Cooling Hair Removal Device" intended for "removal of unwanted body hair" and "hair reduction." It explicitly states that "this function [cooling] has no other therapeutic use." These descriptions indicate a cosmetic or aesthetic purpose rather than a therapeutic one (treatment or diagnosis of a disease or condition).
No
The device is intended for hair removal, a cosmetic/therapeutic purpose, and does not state any function for diagnosing medical conditions.
No
The device description explicitly mentions hardware components such as a Xenon lamp, a built-in skin sensor, and a cooling function, indicating it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The IPL Cooling Hair Removal Device uses light energy to reduce hair growth on the body. It interacts directly with the skin and hair follicles on the body.
- Intended Use: The intended use is for "removal of unwanted body hair," which is a cosmetic or aesthetic purpose, not a diagnostic one.
- Mechanism of Action: The device's mechanism involves applying light energy to the skin, not analyzing biological samples.
The information provided clearly describes a device that operates in vivo (within the living body) for a non-diagnostic purpose.
N/A
Intended Use / Indications for Use
IPI Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
The subject device IPL Cooling 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 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 IPL Cooling Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
There are SKB-2008, SKB-2128, SKB-2188, and SKB-2118 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, and wavelength range, also their energy outputs are slight differences, but these parameters are within the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
personal, 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)
- Biocompatibility Safety
The materials of the patient-directly contacting components of the subject device is ABS plastic and 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:
- 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
- Electrical Safety and Eve 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
- Eye Safety
- 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.
Summary: Based on the above performance as documented in this application, the subject device was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 and 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.
December 1, 2022
Shenzhen Siken 3D Technology Development Co., Ltd. % Rain Yip Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Contact Address
Re: K222710
Trade/Device Name: IPL Cooling Hair Removal 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: August 31, 2022 Received: September 8, 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
1
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,
Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain, with a faint watermark-like design that does not obscure the text.
Jianting Wang, Ph.D. Acting 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
2
Indications for Use
510(k) Number (if known) K222710
Device Name
IPL Cooling Hair Removal Device, model(s): SKB-2008, SKB-2128, SKB-2188, SKB-2118
Indications for Use (Describe)
IPL Cooling Hair Removal 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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3
510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date: 2022-08-31
I. Submitter
Shenzhen Siken 3D Technology Development Co., Ltd. 4th Building,No.33 Left East Avenue,Songgang, Bao'an District, Shenzhen, Guangdong, China Post code: 518105 Tel.: +86 755 2769 7523
Jingquan Liu R&D director Tel .: +86 150 1255 5680 Email: liudirector@siken3d.com
II. Device
Name of Device: IPL Cooling Hair Removal Device Model(s): SKB-2008, SKB-2128, SKB-2188, SKB-2118 Common or Usual Name: Light Based Over-The-Counter For 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
Predicate device: 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: May 12, 2022
IV. Device Description
The subject device IPL Cooling 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 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 IPL Cooling Hair Removal Device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device contains a Xenon lamp and its built-in skin
4
sensor to detect appropriate skin contact. If the device is not properly and fully applied to the treated skin, the device will not emit the light pulse. Also, the subject device is equipped with cooling function to cool down the skin temperature and give a user a better experience, but this function has no other therapeutic use.
There are SKB-2008, SKB-2128, SKB-2188, and SKB-2118 four models in this application. Their work principle, function, intended use, structure, and composition are the same, with differences being product appearance, and wavelength range, also their energy outputs are slight differences, but these parameters are within the predicate device.
V. Indications for Use
IPL Cooling Hair Removal 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 Cooling Hair Removal 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 do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device for its intended use. Therefore, the subject device may be found substantially equivalent to its predicate device.
| Comparison
| Elements | Subject Device | Predicate device K221001 |
|---|---|---|
| K Number | Pending | K221001 |
| Trade name | IPL Cooling Hair Removal | |
| Device/SKB-2008, | ||
| SKB-2128, | ||
| SKB-2188, SKB-2118 | IPL Home Use Hair Removal | |
| Device/D-1198 | ||
| Wavelength range | SKB-2008: 590~1100nm | |
| SKB-2128: 550~1100nm | ||
| SKB-2188: 550~1100nm | ||
| SKB-2118: 590~1100nm | 530-1100nm | |
| Energy medium | Xenon Arc Flashlamp | Xenon Arc Flashlamp |
| Energy density | SKB-2008: 2.2~4.0J/ $cm²$ | |
| SKB-2128: 2.2~3.7J/ $cm²$ | ||
| SKB-2188: 2.0~3.7J/ $cm²$ | ||
| SKB-2118: 2.2~3.7J/ $cm²$ | 2.0~4.3J/ $cm²$ | |
| Spot size | 3 $cm²$ | 2.7 $cm²$ |
| Pulse duration | 10+/-5ms | 5~12ms |
| Pulsing control | Finger switch | Finger switch |
| Delivery device | Direct illumination to tissue | Direct illumination to tissue |
| Indication | ||
| for | IPL Cooling Hair Removal Device | IPL Home Use Hair Removal |
The subject device is compared with the following Predicate Device in terms of intended use, design, specifications, and performance:
5
| Comparison
| Elements | Subject Device | Predicate device K221001 |
|---|---|---|
| use/Intended use | is an over-the-counter device intended for removal of unwanted body hair. | Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. |
| Location for use | OTC | OTC |
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 ABS plastic and 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:
-
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 and Eve 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 was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. Conclusions
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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 Cooling Hair Removal Device is to be concluded substantial equivalent to its predicate device.