Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K

K221569 · Shenzhen Fansizhe Science and Technology Co., Ltd. · OHT · Jun 30, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K221569
• Device Name: Intense Pulsed Light (IPL) System, model: T013C, T015C, T015K
• Applicant: Shenzhen Fansizhe Science and Technology Co., Ltd.
• Product Code: OHT · General, Plastic Surgery
• Decision Date: Jun 30, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Intense Pulsed Light (IPL) System is an over-the-counter device intended for the removal of unwanted body hair.

Device Story

Over-the-counter IPL device for permanent hair reduction; utilizes Xenon Arc Flashlamp to emit light (510nm-1200nm) below skin surface; thermal effect reduces hair growth without cutting or pulling. Includes main unit, external power adapter, and goggles. Features ice-cool technology for comfort. Operated by user at home via finger switch or auto-emission mode. Output energy and fluence parameters are controlled by internal software. Device provides non-invasive hair removal; benefits include minimal pain and convenience of home use.

Clinical Evidence

No clinical data. Bench testing only, including electrical safety, EMC, photobiological safety, and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Xenon Arc Flashlamp source; 510-1200nm wavelength. Materials: PC (T013C shell), ABS (T015C/T015K shell), aluminum (cold compress panel). Powered by external 24Vdc adapter. Standards: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471. Software life cycle per IEC 62304.

Indications for Use

Indicated for removal of unwanted body hair in adult patients.

Regulatory Classification

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.

Predicate Devices

• Intense Pulsed Light (IPL) System (K212881)

Reference Devices

• TB-1755 (K183217)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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

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#### Indications for Use

510(k) Number (if known)

K221569

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.,<br>Ltd |
| Address: | 2nd and 3rd floors, No.17, Xinfa 2nd Road, Xinqiao<br>Community, Xinqiao Street, Baoan District,<br>Shenzhen, Guangdong, China |
| Contact Person of applicant: | |
| Name: | Endang Cheng |
| Address: | 2nd and 3rd floors, No.17, Xinfa 2nd Road, Xinqiao<br>Community, Xinqiao Street, Baoan District,<br>Shenzhen, Guangdong, China |
| TEL: | [phone] |
| Email: | [e-mail] |
| Contact Person of the Submission: | |
| Name: | You Yijie |
| Address: | RM.406, Building C, Run Science Park, No.18<br>Shenzhou Road, Huangpu, Guangzhou,<br>Guangdong 510663 P.R.China |
| TEL: | ([phone] |
| FAX: | ([phone] |
| Email: | [e-mail] |

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<br>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<br>Co., Ltd |
|--------------------------|--------------------------------------------------------------------------|
| 510(K) Number: | K212881 |
| Trade Name: | Intense Pulsed Light (IPL) System |
| Model: | T012C |
| Classification name: | Powered Light Based Non-Laser Surgical<br>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<br>Comparisons | Subject device<br>(Intense Pulsed Light (IPL) System,<br>model: T013C, T015C, T015K) | Predicate device<br>(Intense Pulsed Light (IPL)<br>System,<br>model: T012C) | Discussion of<br>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<br>an over-the-counter device intended for<br>the removal of unwanted body hair. | The Intense Pulsed Light (IPL)<br>System is an over-the-counter<br>device intended for the removal of<br>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<br>contact<br>components | The patients' skin or operator contact:<br>T013C:<br>PC for shell(Lamp shell, button, light<br>guide column, right shell, face shell,<br>front upper shell), aluminum for cold<br>compress panel<br>T015C&T015K: ABS for ABS shell and<br>buttons, aluminum for cold compress<br>panel | The patients' skin or operator<br>contact:<br>ABS for ABS shell and buttons,<br>aluminum for cold compress<br>panel | The material of<br>T015C and<br>T015K is<br>identical with<br>predicate device,<br>T013C is<br>different with<br>predicate device,<br>(Discussion is<br>indicated in D1) |
| Biocompatibility<br>testing | 1.Type of contact: direct contact for<br>users and patients.<br>2.Nature of body contact category:<br>Surface Contact class: A (<24 h)<br>3.Meets ISO 10993- 5, ISO 10993-10 | 1.Type of contact: direct contact<br>for users and patients.<br>2.Nature of body contact<br>category: Surface Contact class:<br>A (<24 h)<br>3.Meets ISO 10993- 5, ISO 10993-<br>10 | Same |
| Single Patient,<br>multi-use | Yes | Yes | Same |
| Patient Interface | Buttons | Buttons | Same |
| Technology | Intense Pulse Light (IPL) | Intense Pulse Light (IPL) | Same |
| Dimensions | 171×76×50mm for T013C<br>206×113×91.5mm for T015C<br>206×113×91.5mm for T015K | 148×190×56mm | Different (Discussi<br>on is indicated in<br>D2) |
| Power source | an external power supply<br>Input: 100-240V ~ 50/60Hz, 1.5A Max.<br>Output: 24Vdc 2.2A | an external power supply<br>Input: 100-240V ~ 50/60Hz, 1.5A<br>Max. Output: 24Vdc 2.2A | Same |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength | 510nm~1200nm | 510nm~1200nm | Same |
| Spot Size | 4cm² for T013C<br>3.5cm² for T015C<br>3.7cm² for T015K | Light outlet: 4cm²<br>Lamp cover: 1.85cm² | Minor<br>different(Discussi<br>on is indicated in<br>D3) |
| Max. Fluence<br>(J/cm²) | 4.03J/cm² for T013C<br>4.69J/cm² for T015C<br>3.6J/cm² for T015K | 5.18J/cm²<br>(Attach Probe Cover:3.41J/cm²) | Different (Discussi<br>on is indicated in<br>D4) |
| Pulse duration | 4~12ms for T013C and T015C<br>3~10ms for T015K | 4~12ms | The parameter of<br>T013C and<br>T015C is<br>identical with<br>predicate device,<br>T013K is minor<br>different with<br>predicate device<br>(Discussion is<br>indicated in D5) |
| Output energy | 3.8J~16.1J for T013C<br>4.1J~16.4J for T015C<br>5.2J~13.4J for T015K | 5.5J~20.7J | Different(Discussion is indicated in D6) |
| Pulsing<br>Control | Finger switch | Finger switch | Same |
| Output<br>Channel | One channel | One channel | Same |
| Delivery | Direct Illumination to Tissue | Direct Illumination to Tissue | Same |
| Software<br>Control | Yes | Yes | Same |
| Operating<br>environment | Temperature: 5-30 °C<br>Relative humidity: 20-90%,<br>without condensation<br>Atmospheric Pressure: 70 kPa to 106 kPa | Temperature: 5-30 °C<br>Relative humidity: 20-90%,<br>without condensation<br>Atmospheric Pressure: 70 kPa to 106 kPa | Same |
| Storage and<br>transportation<br>environment | Temperature: -20 -55 °C<br>Relative humidity: 5-95%,<br>without condensation<br>Atmospheric Pressure: 70 kPa to 106 kPa | Temperature: -20 -55 °C<br>Relative humidity: 5-95%,<br>without condensation<br>Atmospheric Pressure:70 kPa to 106 kPa | Same |
| Electrical<br>safety, EMC,<br>Biological<br>Evaluation | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 62471<br>ISO 10993-5<br>ISO 10993-10 | ANSI AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-1-11<br>IEC 60601-2-83<br>IEC 62471<br>ISO 10993-5<br>ISO 10993-10 | Same |

#### compared to the predicate devices (K212881)

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Based on the comparison chart above, there have been no changes to the intended use or product specifications of subject device from those of the predicate device, the fundamental operating principle of the device is identical to that of the predicate device. The change associated with the updated industrial design which include a different PCB layout and some different hardware components, patient contact material, and minor different specifications, have been verified and validated via laboratory testing. Through the verification and validation process, it has been shown that the differences do not raise new questions of safety and effectiveness.

#### The discussion of differences exist between the subject and predicate devices is listed in following:

- D1: The material of T015C and T015K is identical with predicate device,T013C is different with predicate device. The subject devices have 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.
- D2: The difference of dimensions will not affect the safety and effectiveness.
- D3: Spot Size of subject device is same or similar with predicate device. The safety and effectiveness of the subject device is verified via tests according to ANSI AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.

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- D4: Max. Fluence of subject device is within the range of predicate device. The safety and effectiveness of the subject device is verified via tests according to ANSI AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.
- D5: Pulse duration of T013C and T015C is identical with predicate device,T013K is minor different with predicate device, but similar and within the range of predicate device. The safety and effectiveness of the subject device is verified via tests according to ANSI AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.
- D6: Output energy of subject device is within the range of predicate device. The safety and effectiveness of the subject device is verified via tests according to ANSI AAMI ES60601-1, IEC60601-1-2, IEC60601-1-11, IEC 62471 and IEC 60601-2-83, so the differences do not affect the safety and effectiveness.

# 7. Discussion of Non-Clinical Tests Performed for Safety and

### effectiveness are as follows

The modifications to the device have been designed and assessed under design control processes compliant with FDA 21 CFR 820. Based on modification clearance, a risk analysis was conducted to assess the impact of the changes on the subject device using internal design control procedures and a fault tree analysis described in the FDA-recognized version of ISO 14971.

These risks were mitigated using planned measures that included testing to recognized FDA consensus standards. Changes in software were verified and validated using the software development process.

Non-clinical testing as below table has been performed to demonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate.

| Standards | Standards Name | Results |
|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ANSI AAMI ES60601-<br>1:2005/(R)2012 and<br>A1:2012 | Medical Electrical Equipment -<br>Part 1: General Requirements<br>For Basic Safety And Essential<br>Performance | Pass |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment --<br>Part 1-2: General Requirements<br>For Basic Safety And Essential<br>Performance -- Collateral<br>Standard: Electromagnetic<br>Disturbances -- Requirements<br>And Tests | Pass |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment -<br>Part 1-2: General Requirements<br>For Basic Safety And Essential<br>Performance - Collateral<br>Standard: Electromagnetic<br>Disturbances - Requirements<br>And Tests | Pass |

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| IEC 60601-2-83:2019 | Medical electrical equipment<br>Part 2-83:Particular<br>requirements for the basic<br>safety and essential<br>performance of home light<br>therapy equipment | Pass |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| IEC 62471: 2006 | Photobiological safety of lamps<br>and lamp systems | Pass |
| ISO 10993-5:2009 | Biological evaluation of medical<br>devices - Part 5: Tests for in<br>vitro cytotoxicity | Pass |
| ISO 10993-10:2010 | Biological evaluation of medical<br>devices - Part 10: Tests for<br>irritation and skin sensitization | Pass |
| IEC<br>62304:2006+A1:2015 | Medical device software -<br>Software life cycle processes | Pass |

# 8. Discussion of Clinical Accuracy Testing Performed

There was no clinical testing performed.

## 9. Conclusions

A risk analysis was performed to identify risks associated with the device modifications. Verification and validation tests have been performed to demonstrate that the identified risks have been mitigated. Thus, based on the information provided in this premarket notification, it is concluded that the modified device Intense Pulsed Light (IPL) Systems, model: T013C, T015C, T015K are substantially equivalent to the legally marketed predicate device.