(55 days)
Not Found
No
The description focuses on standard IPL technology and a skin contact sensor, with no mention of AI or ML capabilities. The model name "AI01" is the only potential indicator, but the technical description does not support it.
No.
The device is intended for the removal of unwanted body hair and permanent reduction of hair growth, which are cosmetic purposes, not therapeutic.
No
Explanation: A diagnostic device is used to identify the nature or cause of a disease or condition. This device is an IPL hair removal device, which is intended for the removal of unwanted body hair, a cosmetic purpose, not for diagnosing any medical condition.
No
The device description clearly outlines hardware components such as a Xenon Arc Flashlamp, skin sensor, main unit, adaptor, and accessories, indicating it is a physical device utilizing IPL technology, not software only.
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 testing is done outside of the body ("in vitro").
- This Device's Function: The IPL Hair Removal Device works on the body's surface to reduce hair growth using light energy. It does not involve analyzing any biological samples taken from the body.
The provided information clearly describes a device that interacts directly with the skin for a cosmetic/aesthetic purpose (hair removal), not for diagnostic testing of biological samples.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device (Model: AI01) is intended for the removal of unwanted body hair.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
IPL Hair Removal Device, model: Al01 is a 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 finger switch. The device contains a Xenon Arc Flashlamp and a skin sensor 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. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. Device includes a main unit, an adaptor, and accessories, accessories include goggle.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
There was no clinical testing performed. Non-clinical tests were performed for safety and effectiveness in accordance with recognized consensus standards.
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 & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 4, 2021
Shenzhen Century Dongyuan Technology Co Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd. Rm.1711, Building K. No.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K212897
Trade/Device Name: IPL Hair Removal Device, model: AI01 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: ONF Dated: August 27, 2021 Received: September 10, 2021
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.
1
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 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,
Purva Pandya 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) K212897
Device Name IPL Hair Removal Device, model: AI01
Indications for Use (Describe)
The IPL Hair Removal Device (Model: AI01) is 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)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Section 5: 510(k) Summary
1. Submitter's Information
Establishment Registration Information
Name: Shenzhen Century Dongyuan Technology Co Ltd. Address: Floor 2, Building B1, Gonghe Fourth Industrial Zone, Shajing Street, Bao'an District, Shenzhen City, Guangdong Province China Contact Person of applicant Name: Zhang Benrong Address: Floor 2, Building B1, Gonghe Fourth Industrial Zone, Shajing Street, Bao'an District, Shenzhen City, Guangdong Province China TEL: +86 18565833539 Email: aijofi01@163.com
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China Floor 2, Building B1, Gonghe Fourth Industrial Zone, Shajing Street, Bao'an District, Shenzhen City, Guangdong Province China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmiq-med.com
Date prepared: Oct. 20, 2021
2. Device Information
| Trade Name: | IPL Hair Removal Device, model: AI01 |
|---|---|
| Classification name: | Laser Surgical Instrument For Use In General And Plastic |
| Surgery And In Dermatology | |
| Common or Usual Name: | Powered Light Based Non-Laser Surgical Instrument With |
| Thermal Effect | |
| Review panel: | General & Plastic Surgery |
| Product code: | ONF |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
4
3. Predicate Device Information
| 510(k) submitter/holder: | Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. |
|---|---|
| 510(K) Number: | K183217 |
| Trade Name: | IPL Hair Removal Device |
| Model: | TB-1755 |
| Classification name: | Laser Surgical Instrument For Use In General And |
| Plastic Surgery And In Dermatology | |
| Review panel: | General & Plastic Surgery |
| Product code: | OHT, ONF |
| Regulation Class: | II |
| Regulation Number: | 878.4810 |
4. Device description
IPL Hair Removal Device, model: Al01 is a 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 finger switch. The device contains a Xenon Arc Flashlamp and a skin sensor 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. The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
Device includes a main unit, an adaptor, and accessories, accessories include goggle.
Principle of operation:
The device works by use of thermal energy of Intense Pulse Light (IPL) to kill hair follicles for hair removal. The device generally targets skin (including dermis, epidermis), underlying soft tissue and hair follicles.
5. Indications for Use
The IPL Hair Removal Device (Model: Al01) is intended for the removal of unwanted body hair.
6. Summary of technological characteristics of device
compared to the predicate devices (K183217)
5
K212897
| SE
Comparisons | Subject device
(IPL Hair Removal Device,
model: AI01) | Predicate device
(IPL Hair Removal Device, Model:
TB-1755) | Discussion of
difference |
|--------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|
| 510K Number | / | K183217 | / |
| Classification | 21CFR 878.4810 | 21CFR 878.4810 | Same |
| Product Code | ONF | OHT, ONF | Same |
| FDA Class | II | II | Same |
| Indications for Use | The IPL Hair Removal Device (Model:
AI01) is intended for the removal of
unwanted body hair. | The IPL Hair Removal Device (Model:
TB-1755) is an Over the Counter
device intended for the removal of
unwanted body hair. | Same
(Discussion is
indicated in
D1) |
| Model | AI01 | TB-1755 | / |
| Environment of Use | Home use | Home use | Same |
| Design | Hand-hold | Hand-hold | Same |
| Patient Population | Adult | Adult | Same |
| Material of Patient
contact
components | PC | ABS | Different
(Discussion is
indicated in
D2) |
| Biocompability
testing | Meets ISO 10993- 5
ISO 10993-10 | Meets ISO 10993- 5
ISO 10993-10 | Same |
| Single Patient,
multi-use | Yes | Yes | Same |
| Patient Interface | Buttons | Buttons | Same |
| Technology | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Same |
| Dimensions | 14020356 | 18272.469.2mm | Different
(Discussion is
indicated in
D3) |
| Power source | an external power supply | an external power supply | Same |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | 510nm1100nm | 510nm1100nm | Same |
| Spot Size | 3.1 cm² | 3.1 cm² | Same |
| Max. Fluence
(J/cm²) | 3.8-5.2 J/cm² | 3.8-5.2 J/cm² | Same |
| Pulse duration | 3 milliseconds | 3 milliseconds | Same |
| Output energy | 12-16 J | 12-16 J | Same |
| Pulsing
Control | Finger switch | Finger switch | Same |
| Output
Channel | One channel | One channel | Same |
| Delivery | Direct Illumination to Tissue | Direct Illumination to Tissue | Same |
| Software | Yes | Yes | Same |
| Control | | | |
| Electrical
safety, EMC,
Biological
Evaluation | IEC 60601-1 | IEC 60601-1 | Same |
| | IEC 60601-1-2 | IEC 60601-1-2 | |
| | IEC 60601-1-11 | IEC 60601-1-11 | |
| | IEC 60601-2-57 | IEC 60601-2-57 | |
| | IEC 62471 | IEC 62471 | |
| | ISO 10993-5 | ISO 10993-5 | |
| | ISO 10993-10 | ISO 10993-10 | |
6
K212897
The discussion of differences exist between the subject and predicate devices is listed in following:
- D1: The subject device has same indication with equivalent device regarding remove unwanted hair, the difference is that the equivalent device is for OTC use and the subject device is for Prescription Use, this difference does not raise new questions of safety.
- D2: The subject device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10 with positive results, therefore, the material difference of subject device with Predicate device TB-1755 (K183217) do not raise new questions of safety and effectiveness.
- D3: The difference of dimensions will not affect the safety and effectiveness.
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 60601-2-57:2011 for performance and IEC 62304 for software verification, and ISO 10993-5:2009 for Cytotoxicity endpoints, ISO 10993-10:2010 for Sensitization and Irritation endpoints 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 Requirements |
| For Basic Safety And Essential Performance | |
| IEC 60601-1-2: 2014 | 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 | Medical Electrical Equipment - Part 1-2: General Requirements |
| For Basic Safety And Essential Performance - Collateral |
7
| | Standard: Electromagnetic Disturbances - Requirements And
Tests |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ISO 60601-2-57: 2011 | Particular requirements for the basic safety and essential
performance of non-laser light source equipment intended for
therapeutic, diagnostic, monitoring and cosmetic/aesthetic use |
| IEC 62471: 2006 | Photobiological safety of lamps and lamp systems |
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests for
irritation 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 IPL Hair Removal Device, model Al01 is as safe, as effective, and performs as well as the legally marketed predicate device.