IPL Treatment Systems

K200746 · Shanghai Apolo Medical Technology Co., Ltd. · ONF · May 15, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K200746
• Device Name: IPL Treatment Systems
• Applicant: Shanghai Apolo Medical Technology Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: May 15, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IPL treatment system is intended for medical use in the treatment of the following dermatologic conditions: - Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen; - Moderate inflammatory acne vulgaris; - Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); - Cutaneous lesions including scars; - Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

Device Story

IPL Treatment Systems utilize intense, broad-spectrum pulsed light (420-1200 nm) generated by a Xenon flash lamp. Device consists of main unit, control panel, and interchangeable treatment handpieces. Principle of operation: selective photothermolysis; optical energy absorbed by specific skin chromophores and converted to heat. Interchangeable filters allow selective targeting for specific indications. Cooling system (water, forced-air, copper, TEC) integrated into handpiece to protect epidermis, reduce pain/discomfort, and minimize thermal injury. Used in clinical settings by trained professionals. Output is pulsed light energy; healthcare providers select parameters based on skin type and condition to achieve therapeutic effects like hair reduction or lesion treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), and non-laser light source performance (IEC 60601-2-57). Biocompatibility testing (cytotoxicity, skin irritation, skin sensitization) performed per ISO 10993-1.

Technological Characteristics

Intense pulsed light (Xenon flash lamp) source; 420-1200 nm wavelength; 4.1-50.8 J/cm² fluence; 5-50 ms pulse duration. Direct sapphire coupling delivery. Cooling: water, forced-air, copper, and TEC. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57. Biocompatible materials per ISO 10993-1.

Indications for Use

Indicated for patients requiring treatment of dermatologic conditions including permanent hair reduction, moderate inflammatory acne vulgaris, benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides), cutaneous lesions (scars), and benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, leg veins, spider angiomas, venous malformations).

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

• iPulseLight IPL System (HS 300C, HS 650) (K093627)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a caduceus, which is a traditional symbol of medicine. The text on the right is in blue and is arranged in three lines.

Shanghai Apolo Medical Technology Co., Ltd. Felix Li RA Supervisor 4F, Building A, No.388, Yindu Road, Xuhui District Shanghai, Shanghai 200231 China

Re: K200746

Trade/Device Name: IPL Treatment Systems 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: March 9, 2020 Received: March 23, 2020

Dear Felix Li:

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 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

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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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Colin Kejing Chen 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) k200746

Device Name IPL Treatment System

Indications for Use (Describe)

The IPL treatment system is intended for medical use in the treatment of the following dermatologic conditions:

- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;

- Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);

- Cutaneous lesions including scars;

- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leg telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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# Section 3-510(k) summary

#### l Submitter

Shanghai Apolo Medical Technology Co., Ltd. 4F, Building A, No.388, Yindu Road, Xuhui District, Shanghai 200231, China

Establishment Registration Number: 3007120647

Contact person: Felix Li Position: Regulatory Affairs Phone: [phone] Fax: [phone] E-mail: [e-mail]

Date of preparation: Apr 28th, 2020

#### II Proposed Device

| Trade Name of Device: | IPL Treatment Systems |
|-----------------------|----------------------------------------------------------------------------------------|
| Common name: | Laser surgical instrument for use in general and plastic surgery<br>and in dermatology |
| Regulation Number: | 21 CFR 878.4810 |
| Regulatory Class: | Class II |
| Product code: | ONF |
| Review Panel | General & Plastic Surgery |

#### III Predicate Devices

| 510(k) Number: | K093627 |
|-----------------|----------------------------------------------------------------------------------------|
| Trade name: | iPulseLight IPL System (HS 300C, HS 650) |
| Common name: | Laser surgical instrument for use in general and plastic<br>surgery and in dermatology |
| Classification: | Class II |
| Product Code: | ONF |
| Manufacturer | Shanghai APOLO Medical Technology Co., Ltd. |

#### IV Device description

The IPL Treatment Systems utilizes an intense, visible, broad-spectrum pulse of light that when used with interchangeable filters, allowing it to selectively heat the target

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for different indications. The optical component is intended to drive the IPL energy to concentrate where the optical energy has selectively heated the target.

The Intense pulsed light (IPL) is a type of intensive, broadband, coherent light source which has a wavelength spectrum of 420 nm -1200 nm. The light-based component delivers optical energy that is absorbed by specific chromophores in the skin, which is converted to heat, according to the principle of selective photothermolysis.

The proposed device consists of the main unit, control panel and the treatment handpiece(s).

#### V Indication for use

The IPL treatment systems is intended for medical use in the treatment of the following dermatologic conditions:

- Permanent hair reduction- long-term stable reduction in number of hairs re-growing after a treatment regimen;
- -Moderate inflammatory acne vulgaris;
- Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
- -Cutaneous lesions including scars;
- Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial truncal and leq telangiectasias, erythema of rosacea, leg veins, spider angiomas and venous malformations.

| Item | Proposed device | Predicate device<br>(K093627) | Discussion |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Product<br>Code | ONF | ONF | Identical |
| Regulation<br>No. | 21 CFR 878.4810 | 21 CFR 878.4810 | Identical |
| Class | Class II | Class II | Identical |
| Indication<br>for use | The IPL treatment<br>systems is intended for<br>medical use in the<br>treatment of the following<br>dermatologic conditions:<br>- Permanent hair<br>reduction- long-term | iPulseLight IPL System (HS<br>300C, HS 650) are identical<br>with regard to indications<br>for use including<br>recommended filters to be<br>used with Fitzpatrick skin<br>type. Both models are | The<br>indications<br>of<br>the<br>proposed<br>device<br>covered by<br>the |
| | stable reduction in<br>number of hairs<br>re-growing after a<br>treatment regimen; | intended for medical use in<br>the treatment of the<br>following dermatologic<br>conditions: | predicate.<br>The cooling<br>system is<br>an integral<br>part of the<br>device. |
| - | Moderate<br>inflammatory acne<br>vulgaris; | Permanent hair<br>reduction- long-term<br>stable reduction in<br>number of hairs<br>re-growing after a<br>treatment regimen. | |
| - | Benign pigmented<br>epidermal lesions<br>including dyschromia,<br>hyperpigmentation,<br>melasma, ephelides<br>(freckles); | Treatment of: | |
| - | Cutaneous lesions<br>including scars; | • Moderate<br>inflammatory acne<br>vulgaris | |
| - | Benign cutaneous<br>vascular lesions<br>including port wine<br>stains, hemangiomas,<br>facial truncal and leg<br>telangiectasias,<br>erythema of rosacea,<br>leg veins, spider<br>angiomas and venous<br>malformations. | • Benign pigmented<br>epidermal lesions<br>including<br>dyschromia,<br>hyperpigmentation,<br>melasma,<br>ephelides<br>(freckles). | |
| | | • Cutaneous lesions<br>including scars | |
| | | • Benign cutaneous<br>vascular lesions<br>including port wine<br>stains,<br>hemangiomas,<br>facial, truncal and<br>leg telangiectasia,<br>erythema of<br>rosacea, leg veins,<br>spider angiomas<br>and venous<br>malformations. | |
| | | The integrated thermal<br>cooling is indicated for use<br>in cooling the epidermis at | |
| | | the treatment site prior to, | |
| | | during, and after light | |
| | | treatment in general | |
| | | aesthetic dermatologic and | |
| | | plastic surgery procedures. | |
| | | - Reduce pain during light | |
| | | treatment (via partial | |
| | | anesthesia from | |
| | | cooling) | |
| | | - Reduce discomfort | |
| | | during and/or | |
| | | associated with light | |
| | | treatment | |
| | | - Minimize thermal injury, | |
| | | including thermal | |
| | | necrosis, to non-target | |
| | | skin and skin structures | |
| | | during and/or | |
| | | associated with light | |
| | | treatment, thus reducing | |
| | | possible complications | |
| | | such as scabbing, | |
| | | scarring, hyper - and/or | |
| | | hypo pigmentation | |
| | | - Allow the use of higher | |
| | | light or laser fluencies | |
| | | for light treatments | |
| | | (such as for hair | |
| | | removal and the | |
| | | treatment of vascular or | |
| | | pigmented lesions) | |
| | | - Reduce potential side | |
| | | effects of light | |
| | | treatments (such as for | |
| | | hair removal and the | |
| | | treatment of lesions) | |
| Light source | Intense pulsed light<br>(Xenon Flash Lamp) | Intense pulsed light (Xenon<br>Flash Lamp) | Identical |
| Wavelength | 420 – 1200 nm | 420 – 1200 nm | Identical |
| | | | |
| range | | | |
| Hanpiece ports | HS-650K&HS-660K: 2<br>HS620K, HS-300CK &<br>HS-310K: 1 | HS 650: 2<br>HS 300C: 1 | Identical |
| Structure | HS-650K&HS-660K:<br>Vertical<br>HS620K, HS-300CK &<br>HS-310K: Table top | HS 650: Vertical<br>HS 300C: Table top | Identical |
| Energy output | 4.1-50.8 J/cm² | 10-50 J/cm² | Equivalent |
| Pulse width | 5-20 ms | 2-20 ms | Equivalent |
| Pulse duration | 5-50 ms | 5-50 ms | Identical |
| Spot size | 12*35mm, 15*50mm | 12*35mm, 15*50mm | Identical |
| Filters | 420 -1200nm: Acne;<br>510 -1200nm: Acne,<br>vascular, pigment;<br>560 -1200nm: Acne,<br>vascular, pigment;<br>610-1200nm: Hair<br>removal;<br>640-1200nm: Hair<br>removal;<br>690-1200nm: Hair<br>removal; | 420 -1200nm: Acne;<br>510 -1200nm: Acne,<br>vascular, pigment;<br>560 -1200nm: Acne,<br>vascular, pigment;<br>610-1200nm: Hair removal;<br>640-1200nm: Hair removal;<br>690-1200nm: Hair removal; | Identical |
| Fluences | 420 -1200nm:<br>4.1-50.8J/cm²;<br>510 -1200nm: 3.8-47<br>J/cm²;<br>560 -1200nm: 3.7-43.3<br>J/cm²;<br>610-1200nm: 3.5-38.7<br>J/cm²;<br>640-1200nm:<br>3.3-37.4J/cm²;<br>690-1200nm:<br>3.1-33.4J/cm²; | 420 -1200nm: 10-50J/cm²;<br>510 -1200nm: 9.2-46.35<br>J/cm²;<br>560 -1200nm: 9-42.6 J/cm²;<br>610-1200nm: 8.5-38.1<br>J/cm²;<br>640-1200nm: 8-36.8J/cm²;<br>690-1200nm:<br>7.6-32.9J/cm²; | The<br>fluences for<br>each filter<br>are at<br>similar<br>energy<br>level,<br>considered<br>equivalent. |
| Output mode | Pulse mode | Pulse mode | Identical |
| Deliver<br>materials | Direct sapphire Coupling | Direct sapphire Coupling | Identical |
| Cooling<br>method | HS-650K&HS-660K:<br>Water cooling, forced-air<br>cooling, copper and TEC;<br><br>HS620K,<br>HS-300CK&HS-310K:<br>Water cooling and<br>forced-air cooling, | TEC and circulating water &<br>air | Equivalent |

# VI Comparison of technological characteristics with the predicate devices

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# VII Non-Clinical Testing

A series of tests have been performed to verity that the proposed device met all design specification. The test result demonstrated that the proposed device complies with the following standards:

## Electrical safety and electromagnetic compatibility

- IEC 60601-1: 2005+corr.1:2006+Corr.2.2007+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 60601-2-57: 2011 Medical electrical equipment Part 2: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

## Biocompatibility Evaluation:

The contact material of the proposed device is identical to that of the iPulseLight IPL System cleared in K093627.

Per FDA's Biocompatibility Guidance issued on June 16, 2016 and with regard to Table A.1 Evaluation Tests for consideration in ISO, "Use of international Standard ISO 10993-1, Biological evaluation of medical - Part 1: Evaluation and testing within a risk management process," the following tests performed on the material which contacts with human for Biocompatibility:

- Cytotoxicity;
- Skin irritation; ●
- Skin Sensitization .; ●

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# VIII Clinical Testing

It is not applicable.

IX Conclusion substantially equivalent to the predicate device.