(88 days)
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth 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 device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.
Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.
Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.
The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
The provided text is a 510(k) summary for an Intense Pulsed Light (IPL) System. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study acceptance criteria and results for the new device's performance.
Therefore, the document explicitly states: "There was no clinical testing performed."
As such, the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria (including sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set information) is not available in the provided text.
The document primarily discusses non-clinical tests performed to ensure safety and effectiveness by complying with recognized consensus standards (e.g., electrical safety, EMC, biocompatibility, software verification). The "Discussion of Non-Clinical Tests Performed for Safety and effectiveness" section lists these standards but does not provide specific performance metrics or acceptance criteria related to a clinical outcome of hair removal effectiveness for the subject device.
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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" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
March 28, 2023
Shenzhen Fansizhe Science and Technology Co., Ltd % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. RM.406, Building C, Run Science Park, No.18 Shenzhou Road, Huangpu Guangzhou, Guangdong 510663 China
Re: K223928
Trade/Device Name: Intense Pulsed Light (IPL) System, model: T023A, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001A, T001N, T001N, T011C, T016K 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: December 29, 2022 Received: December 30, 2022
Dear You Yijie:
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 (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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Intense Pulsed Light (IPL) System, model:T023K, T023B, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T001N, T011C, T016K
Indications for Use (Describe)
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the 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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
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Section 5: 510(k) Summary
1. Submitters Information
Establishment Registration Information
| Name: | Shenzhen Fansizhe Science And Technology Co., Ltd |
|---|---|
| Address: | 2nd, 3rd And 4th Floors, No.11, Henggangxia IndustrialZone, Xiangshan Community, Xinqiao Street, Bao'anDistrict, Shenzhen, Guangdong, China |
| Contact Person of applicant: | |
| Name: | Endang Cheng |
| Address: | 2nd, 3rd And 4th Floors, No.11, Henggangxia IndustrialZone, Xiangshan Community, Xinqiao Street, Bao'anDistrict, Shenzhen, Guangdong, China |
| TEL: | +86 18617061709 |
| Email: | ChengEndang1001@163.com |
| Contact Person of the Submission: | |
| Name: | You Yijie |
| Address: | RM.406, Building C, Run Science Park, No.18Shenzhou Road, Huangpu, Guangzhou, Guangdong510663 P.R. China |
| TEL: | (+86)020-82245821 |
| FAX: | (+86)020-82245821 |
| Email: | jet.you@qimmiq-med.com |
Date prepared: Dec. 29, 2022
2. Device Information
| Trade Name: | Intense Pulsed Light (IPL) System |
|---|---|
| Model: | T023K, T023A, T023B, T023C, T023D, T023E, T021K,T021A, T001A, T001B, T001M, T001N, T011C, T016K |
| Classification name: | Light Based Over-The-Counter Hair Removal |
| Common or Usual Name: | Powered Light Based Non-Laser Surgical Instrument WithThermal Effect |
| Review panel: | General Plastic Surgery |
| Product code: | OHT |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
3. Predicate Device Information
| 510(k) | Shenzhen Yuwei Electronic Technology Co., Ltd. |
|---|---|
| submitter/holder: |
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510(K) Number: K220222 Trade Name: IPL Hair Removal Device S1-A, S2-A, S1, S2, S3, S4 Model: Classification name: Light Based Over-The-Counter Hair Removal Review panel: General Plastic Surgery Product code: OHT Regulation Class: Regulation Number: 878.4810
4. Device description
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K, are a small over-the-counter device for the permanent reduction of hair growth 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 device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Intense Pulsed Light (IPL) System, models: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001N, Contains a Xenon arc flashlamp, a touch chip to detect appropriate skin contact, and a skin color sensor to detect the skin color. In "Skin Color Recognition mode", the device's skin sensor automatically detects skin tone for your protection. If your skin tone is not in tone table for treatment, the device must not be used. You need to identify your skin tone before treatment according to skin tone table, and confirm whether the product is applicable to you after the skin color sensor detects a skin tone.
Intense Pulsed Light (IPL) System, models: T011C and T016K, contains a Xenon arc flashlamp, and a touch chip to detect appropriate skin contact. If the device is not properly applied to the treatment area (in full contact with the skin), the device cannot emit the treatment light pulses.
Based on the cooling technology, Intense Pulsed Light (IPL) System, models: T023A, T023B, T023D, T023E, T021K, T021A, T011C, T016K, has cooling care functions. When the cooling care mode is enabled, it can reduce the excessive heat generated on the skin by the photon irradiation and do cooling compresses during hair removal.
The Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles.
The device is intended to be used for adults aged over 18.
Principle of operation:
Hair has a growth cycle, which can be roughly divided into incubation period, growth period and decline period. The growth period hair has a complete structure such as hair follicles and hair shafts. The hair in the incubation period and the decline period does not have the hair follicle structure. The removal of excess hair is to take advantage of the characteristics of the anatomical structure of hair. The device based on the IPL technology emits a specific wavelength of the light and delivers the light to the skin. It is designed to help break the cycle of hair re-growth. Light energy is transferred through the skin's surface and is absorbed by melanin present in the hair shaft. The absorbed light energy is converted to heat energy below the surface of the skin, which disables the hair follicle preventing further growth. Therefore, the device achieves effective hair removal.
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5. Indications for Use
The Intense Pulsed Light (IPL) System (Model: T023K, T023B, T023C, T023D, T023E, T021K, T021A, T001A, T001B, T001M, T011C, T016K) is an over-the-counter device intended for the removal of unwanted body hair.
6. Summary of technological characteristics of device compared to the
predicate devices (K220222)
| SEComparisons | Subject device(Intense Pulsed Light (IPL) System,model: T023K, T023A, T023B, T023C,T023D, T023E, T021K, T021A, T001A,T001B, T001M, T001N, T011C, T016K) | Predicate device(IPL Hair Removal Device, Model:S1-A, S2-A, S1, S2, S3, S4) | Discussion ofdifference |
|---|---|---|---|
| 510K Number | / | K220222 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT | OHT | Same |
| FDA Class | II | II | Same |
| Indications for Use | The Intense Pulsed Light (IPL) System isan over-the-counter device intended forthe removal of unwanted body hair. | IPL Hair Removal Device is an over-the-counter device intended forremoval of unwanted bodyhair. | Same |
| Model | T023K, T023A, T023B, T023C, T023D,T023E, T021K, T021A, T001A, T001B,T001M, T001N, T011C, T016K | S1-A, S2-A, S1, S2, S3, S4 | / |
| Environment of Use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Same |
| Material of Patientcontactcomponents | T023K, T023A: PC for button, PC for mainhousing and Probe cover, SapphireCrystal Cooling Compress;T023B, T023C: PC for button, PC formain housing and Probe cover, SapphireCrystal Cooling Compress;T023D, T023E: PC for button, PC formain housing and Probe cover, SapphireCrystal Cooling Compress;T021K, T021A: PC for button, PC for mainhousing and Probe cover, SapphireCrystal Cooling Compress;T001A, T001B, T001M, T001N: PC forbutton, PC for main housing and Probecover;T011C: PC for main housing, aluminumfor cold compress panel;T016K: PC for button, PC for mainhousing and Probe cover, SapphireCrystal Cooling Compress | ABS | Different(Discussion isindicated inD1) |
| Biocompabilitytesting | 1.Type of contact: direct contact forusers and patients.2.Nature of body contact category: | 1.Type of contact: direct contact forusers and patients.2.Nature of body contact category: | Same |
| Surface Contact class: A (<24 h)3.Meets ISO 10993- 5, ISO 10993-10 | Surface Contact class: A (<24 h)3.Meets ISO 10993- 5, ISO 10993-10 | ||
| Single Patient,multi-use | Yes | Yes | Same |
| Patient Interface | Buttons | Buttons | Same |
| Technology | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Same |
| Dimensions | 116217.842mm for T023K, T023A,T023B, T023C, T023D and T023E,73.281.1202.2mm for T021K and T021A18278151mm for T001A, T001B, T001Mand T001N,21113860mm for T011C,9044225mm for T016K | 18576.556.5mm for S1 and S1-A20777.547.5mm for S2 and S2-A192.57346.5mm for S319976.546.5mm for S4 | Different(Discussion isindicated inD2) |
| Power source | an external power supply | an external power supply | Same |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | 510nm~1200nm | 610-1100nm | Different(Discussion isindicated inD3) |
| Spot Size | 3.0cm² for T023K, T023A, T023B, T023C,T023D, T023E, T021K and T021A,4.0cm² for T001A, T001B, T001M andT001N,3.6cm² for T011C,3.3cm² for T016K | 3.0 cm² for S1-A and S2-A4.1cm² for S1, S2, S3, and S4 | Different(Discussion isindicated inD4) |
| Max. Fluence(J/cm²) | 5.5J/cm² for T023K, T023A, T023B,T023C, T023D and T023E,4.8J/cm² for T021K and T021A,4.7J/cm² for T001A, T001B, T001M andT001N,5.75J/cm² for T011C,5.73J/cm² for T016K | 5.6 J/cm² | Different(Discussion isindicated inD5) |
| Pulse duration | 4 ~ 12ms | 8~14ms | Different(Discussion isindicated inD6) |
| Output energy | 6.5J | 8.7 ~ 16.8J for S1-A and S2-A9.02~16.81J for S1, S2, S3, and S4 | Different(Discussion isindicated inD7) |
| PulsingControl | Finger switch | Finger switch | Same |
| OutputChannel | One channel | One channel | Same |
| Delivery | Direct Illumination to Tissue | Direct Illumination to Tissue | Same |
| SoftwareControl | Yes | Yes | Same |
| Electricalsafety, EMC,BiologicalEvaluation | ANSI AAMI ES60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-83IEC 62471ISO 10993-5ISO 10993-10 | IEC 60601-1IEC 60601-1-2IEC 60601-1-11IEC 60601-2-57IEC 62471ISO 10993-5ISO 10993-10 | Different(Discussion isindicated inD8) |
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7. Discussion of Non-Clinical Tests Performed for Safety and
effectiveness are as follows
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1, IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, IEC 60601-2-83:2011 for performance and IEC 62304 for software verification are complied. See below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| ANSI AAMIES60601-1:2005/(R)2012 A1:2012,C1:2009/(R)2012A2:2010/(R)2012 (Cons. Text)[Incl. AMD2:2021] | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| IEC 60601-1-2:2014+A1:2020 | Medical Electrical Equipment -- Part 1-2: General RequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General RequirementsFor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests |
| IEC 60601-1-11:2015/AMD1:2020 | Medical Electrical Equipment - Part 1-2: General RequirementsFor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests |
| IEC 60601-2-83:2019 | Medical electrical equipment Part 2-83: Particular requirementsfor the basic safety and essential performance of home lighttherapy equipment |
| IEC 62471: 2006 | Photobiological safety of lamps and lamp systems |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
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| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
|---|---|
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices -Guidance for Industry and FDA Staff, May 2005.
8. Discussion of Clinical Accuracy Testing Performed
There was no clinical testing performed.
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Intense Pulsed Light (IPL) System, model: T023K, T023B, T023C, T023C, T023E, T021K, T021A, T001A, T001B, T001M, T011C and T016K, is substantially equivalent to the predicate devices.
§ 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.