Intense Pulsed Light Treatment System

K230816 · Shangdong Huamei Technology Co., Ltd. · ONF · Apr 21, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230816
• Device Name: Intense Pulsed Light Treatment System
• Applicant: Shangdong Huamei Technology Co., Ltd.
• Product Code: ONF · General, Plastic Surgery
• Decision Date: Apr 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Intense Pulsed Light Treatment System (Model: EROSE-YA)) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Device Story

EROSE-YA is an intense pulsed light (IPL) system delivering light at 430-1200nm; operates on principle of selective thermolysis; causes thermal damage to target chromophores while sparing normal skin by limiting pulse width below thermal relaxation time of skin. Device delivers multiple wavelengths per pulse; enhances penetration without excessive energy. Used in clinical settings by trained operators. Output is pulsed light delivered via sapphire handpiece. Healthcare providers use device to treat hair, pigmented lesions, and vascular lesions; clinical benefit is permanent hair reduction and lesion reduction.

Clinical Evidence

No clinical data included. Bench testing only.

Technological Characteristics

IPL system; sapphire crystal handpiece; 430-1200nm wavelength range; 10-50 J/cm2 energy density; 1-20ms pulse width; 5-50ms pulse delay; 2000W max power. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, ISO 10993-5 (cytotoxicity), and ISO 10993-10 (irritation/sensitization).

Indications for Use

Indicated for surgical and aesthetic applications including permanent hair removal, reduction of benign pigmented lesions, and reduction of benign vascular lesions in patients seeking these cosmetic treatments.

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 Treatment System (K192521)

Submission Summary (Full Text)

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April 21, 2023

Shangdong Huamei Technology Co., Ltd. % Ray Wang General Manger Beijing Believe-Med Technology Service Co., Ltd. Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District Beijing, 102401 China

Re: K230816

Trade/Device Name: Intense Pulsed Light Treatment System 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 23, 2023 Received: March 24, 2023

Dear Ray Wang:

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

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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 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,

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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## Indications for Use

Submission Number (if known)

K230816

Device Name

Intense Pulsed Light Treatment System (EROSE-YA)

ndications for Use (Describe)

The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

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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# 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K230816

- 1. Date of Preparation: 03/23/2023
- 2. Sponsor Identification

### Shangdong Huamei Technology Co., Ltd.

No. 588, Changning Street, High-tech District, WeiFang, ShanDong, China, 261205

Contact Person: Yugui Dong Position: Vice-general manager Tel: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Mr. Ray Wang

### Beijing Believe-Med Technology Service Co., Ltd.

Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., FangShan District, Beijing City, China, 102401 Tel: [phone] Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: Intense Pulsed Light Treatment System Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Model(s): EROSE-YA

Regulatory Information:

Classification Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect Classification: II; Product Code: ONF; Regulation Number: 21 CFR 878.4810; Review Panel: General & Plastic Surgery;

Indication For Use Statement:

The Intense Pulsed Light Treatment System (Model: EROSE-YA)) is indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

#### Device Description:

The EROSE-YA device is an intense pulsed light system which delivers intense pulsed light at wavelengths ranging from 430mm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective thermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.

IPL systems are different from lasers in that they deliver many wavelengths in each pulse of light instead of just one wavelength. Generally, IPL enhances penetration without using excessive energy levels and enables targeting of specific chromophores.

- న. Identification of Predicate Device(s)
510(k) Number K192521

Predicate Device Name Intense Pulsed Light Treatment System

Manufacturer Shangdong Huamei Technology Co., Ltd.

Intended Use:

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The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

a) IEC 60601-1-2 :2014/AMD1:2020. Medical Electrical Equipment - Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests.

b) IEC 60601-1:2005+A1:2012+A2:2020, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

c) IEC60601-2-57:2011. Medical electrical equipment -- Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use

d) ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.

e) ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation and delay-type hypersensitivity.

#### 7. Clinical Test Conclusion

No clinical study is included in this submission.

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| | | Predicate Device | |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| ITEM | Proposed Device | Intense Pulsed Light Treatment<br>System (K192521) | Remark |
| Product Code | ONF | ONF | SE |
| Regulation No. | 21 CFR 878.4810 | 21 CFR 878.4810 | SE |
| Class | II | II | SE |
| Intended Use | The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.<br>Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | The Intense Pulsed Light Treatment System (Model: HM-IPL-B8) are indicated for use in surgical and aesthetic applications in permanent hair removal, reduction of benign pigmented lesions and benign vascular lesions.<br>Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. | SE |

#### Substantially Equivalent (SE) Comparison 8.

| | Table 1 General Comparison | | |
|--|----------------------------|--|--|
|--|----------------------------|--|--|

Table 2 Performance Comparison

| ITEM | Proposed Device | Predicate Device<br>Intense Pulsed Light Treatment<br>System (K192521) | Remark |
|----------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------|
| Light source | Intense pulsed light | Intense pulsed light | SE |
| Wavelength | $430-1200nm , 530-1200nm ,640-1200nmOptional : 480nm-1200nm ,560-1200nm, 590-1200nm,690-1200nm, 750nm-1200nm$ | $430-1200nm , 530-1200nm ,640-1200nmOptional : 480nm-1200nm ,560-1200nm, 590-1200nm,690-1200nm, 750nm-1200nm$ | SE |
| Deliver system | Sapphire | Sapphire | SE |
| Energy density | $10-50J/cm2 ±20%error$ | $10-50J/cm2$ | SE |
| Pulse Delay | $5-50ms ±10%error$ | $5-50ms$ | SE |
| Pulse Width | $1-20ms ±10%error$ | $1-20ms$ | SE |
| Max. Power | $2000W$ | $2000W$ | SE |
| Spot size | $15mm×50mm; 80mm×40mm±20%error$ | $15mm×50mm; 80mm×40mm$ | SE |

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| ITEM | Proposed Device | Predicate Device<br>Intense Pulsed Light Treatment<br>System (K192521) | Remark |
|---------------------------------|--------------------------------|------------------------------------------------------------------------|--------|
| <b>permanent hair reduction</b> | | | |
| Wavelength Range<br>(nm) | 640-1200/690-1200/ 750-1200 | 640-1200/690-1200/ 750-1200 | |
| Energy Range<br>(J/cm2) | 10-44 | 10-44 | SE |
| Pulse Width (ms) | 3-14 | 3-14 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |
| <b>pigmented lesions</b> | | | |
| Wavelength Range<br>(nm) | 480-1200/530-1200/560-1200 | 480-1200/530-1200/560-1200 | |
| Energy Range<br>(J/cm2) | 12-44 | 12-44 | SE |
| Pulse Width (ms) | 3-9 | 3-9 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |
| <b>vascular lesions</b> | | | |
| Wavelength Range<br>(nm) | 530-1200/560-1200/<br>590-1200 | 530-1200/560-1200/<br>590-1200 | |
| Energy Range<br>(J/cm2) | 10-42 | 10-42 | SE |
| Pulse Width (ms) | 3-8 | 3-8 | |
| Pulse Delay (ms) | 16-32 | 16-32 | |
| Spot Size (mm) | 15mm×50mm; 80mm×40mm; | 15mm×50mm; 80mm×40mm; | |

Table 3 Setting Comparison of Specified Indication for Use

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| ITEM | Proposed Device<br>EROSE-YA | Predicate Device<br>Intense Pulsed Light Treatment<br>System (K192521) | Remark |
|-----------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------|
| Power supply | $110V \pm 10%$ 60Hz | $110V \pm 10%$ 60Hz | SE |
| Electrical<br>Safety | The proposed devices were tested<br>to demonstrated to comply with<br>IEC 60601-1 | The proposed devices were tested<br>to demonstrated to comply with<br>IEC 60601-1 | SE |
| EMC | The proposed devices were tested<br>to demonstrated to comply with<br>IEC 60601-1-2 | The proposed devices were tested<br>to demonstrated to comply with<br>IEC 60601-1-2 | SE |
| Patient Contact<br>Material | Handpiece (Sapphire Crystal) | Handpiece (Sapphire Crystal) | SE |
| Biocompatibility | | | |
| Cytotoxicity | No toxicity (ISO 10993-5) | No toxicity (ISO 10993-5) | SE |
| Irritation | Applied sample did not induce<br>irritation to skin. (ISO 10993 -10) | Applied sample did not induce<br>irritation to skin. (ISO 10993 -10) | SE |
| Sensitization | The test article showed no<br>signification evidence of causing<br>skin sensitization in the guinea<br>pig .(ISO 10993-10) | The test article showed no<br>signification evidence of causing<br>skin sensitization in the guinea<br>pig .(ISO 10993-10) | SE |

Table 4 Safety Comparison

- 9. Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.