(30 days)
Not Found
No
The summary describes a standard IPL device for hair removal and does not mention any AI or ML components or functionalities.
Yes
The device is intended for the removal of unwanted body hair and aims for the permanent reduction of hair growth, which is a therapeutic purpose even if it's cosmetic.
No
The device's intended use is for the removal of unwanted body hair, which is a therapeutic or cosmetic purpose, not for diagnosing a condition or disease.
No
The device description explicitly states it includes a "main unit, an adaptor and goggles" and utilizes "Intense Pulsed Light (IPL)" technology, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "removal of unwanted body hair." This is a cosmetic or aesthetic procedure performed on the body, not a diagnostic test performed on a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the mechanism of action (IPL working below the skin's surface) and the physical components of the device used for hair removal. It does not mention any analysis of biological samples.
- Anatomical Site: The anatomical site is "body," which is consistent with a device used externally for a physical treatment.
- Input Imaging Modality: While it uses Intense Pulsed Light, this is the energy source for the treatment, not an imaging modality used to analyze a sample for diagnostic purposes.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
Product codes
OHT, ONF
Device Description
Intense Pulsed Light (IPL) System is 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 Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Based on the ice-cool technology, the hair removal device with ice-cold compress functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adult
Intended User / Care Setting
Home 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
Non-clinical testing has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate. The device was subjected to the following tests and passed:
- ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 for Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- IEC 60601-1-2: 2014 for 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: 2015 for Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- IEC 60601-2-83:2019 for Medical electrical equipment Part 2-83:Particular requirements for the basic safety and essential performance of home light therapy equipment
- IEC 62471: 2006 for Photobiological safety of lamps and lamp systems
- ISO 10993-5:2009 for Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 for Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- IEC 62304:2006+A1:2015 for Medical device software - Software life cycle processes
Key Metrics
Not Found
Predicate Device(s)
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 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.
June 30, 2022
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: K221569
Trade/Device Name: Intense Pulsed Light (IPL) System, model: T013C, T015K 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, ONF Dated: May 15, 2022 Received: May 31, 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 and Part 809); 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
510(k) Number (if known)
Device Name
Intense Pulsed Light (IPL) System, model:T013C, T015C, T015K
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)
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Section 5: 510(K) Summary
1. Submitter's Information
| Establishment Registration Information: | |
|---|---|
| Name: | Shenzhen Fansizhe Science And Technology Co., |
| Ltd | |
| Address: | 2nd and 3rd floors, No.17, Xinfa 2nd Road, Xinqiao |
| Community, Xinqiao Street, Baoan District, | |
| Shenzhen, Guangdong, China | |
| Contact Person of applicant: | |
| Name: | Endang Cheng |
| Address: | 2nd and 3rd floors, No.17, Xinfa 2nd Road, Xinqiao |
| Community, Xinqiao Street, Baoan District, | |
| Shenzhen, Guangdong, China | |
| TEL: | +86 0755-85275266 |
| Email: | ChengEndang1001@163.com |
| Contact Person of the Submission: | |
| Name: | You Yijie |
| Address: | RM.406, Building C, Run Science Park, No.18 |
| Shenzhou Road, Huangpu, Guangzhou, | |
| Guangdong 510663 P.R.China | |
| TEL: | (+86)020-82245821 |
| FAX: | (+86)020-82245821 |
| Email: | jet.you@qimmiq-med.com |
Date prepared: May 13, 2022
2. Device Information
| Trade Name: | Intense Pulsed Light (IPL) System |
|---|---|
| Model: | T013C, T015C, T015K |
| Classification name: | Light Based Over-The-Counter Hair Removal |
| Common or Usual Name: | Powered Light Based Non-Laser Surgical Instrument With |
| Thermal Effect | |
| Review panel: | General & Plastic Surgery |
| Product code: | OHT |
| Subsequent Product code: | ONF |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
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3. Predicate Device Information
| 510(k) submitter/holder: | Shenzhen Fansizhe Science And Technology
Co., Ltd |
|--------------------------|--------------------------------------------------------------------------|
| 510(K) Number: | K212881 |
| Trade Name: | Intense Pulsed Light (IPL) System |
| Model: | T012C |
| Classification name: | Powered Light Based Non-Laser Surgical
Instrument With Thermal Effect |
| Review panel: | General & Plastic Surgery |
| Product code: | OHT, ONF |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
4. Device description
Intense Pulsed Light (IPL) System is 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 Intense Pulsed Light (IPL) System includes main unit, an adaptor and goggles. The device is only powered by the external power adapter and its IPL emission activation is by a switch or auto light emission.
Based on the ice-cool technology, the hair removal device with ice-cold compress functions.
5. Indications for Use
The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.
6. Summary of technological characteristics of device
| SE
Comparisons | Subject device
(Intense Pulsed Light (IPL) System,
model: T013C, T015C, T015K) | Predicate device
(Intense Pulsed Light (IPL)
System,
model: T012C) | Discussion of
difference |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510K Number | K221569 | K212881 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | OHT, ONF | OHT, ONF | Same |
| FDA Class | II | II | Same |
| Model | T013C, T015C, T015K | T012C | / |
| Indications for Use | The Intense Pulsed Light (IPL) System is
an over-the-counter device intended for
the removal of unwanted body hair. | The Intense Pulsed Light (IPL)
System is an over-the-counter
device intended for the removal of
unwanted body hair. | Same |
| Type of use | Over-The-Counter Use | Over-The-Counter Use | Same |
| Environment of Use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Same |
| Material of Patient
contact
components | The patients' skin or operator contact:
T013C:
PC for shell(Lamp shell, button, light
guide column, right shell, face shell,
front upper shell), aluminum for cold
compress panel
T015C&T015K: ABS for ABS shell and
buttons, aluminum for cold compress
panel | The patients' skin or operator
contact:
ABS for ABS shell and buttons,
aluminum for cold compress
panel | The material of
T015C and
T015K is
identical with
predicate device,
T013C is
different with
predicate device,
(Discussion is
indicated in D1) |
| Biocompatibility
testing | 1.Type of contact: direct contact for
users and patients.
2.Nature of body contact category:
Surface Contact class: A (