The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair removal. Permanent hair removal 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 USS00 Intense Pulsed Light Equipment is a device that emits intense pulsed light in order to achieve hair reduction. The light source is a Xenon lamp that emits light which is filtered to include suitable wavelengths for hair reduction. The device is electrically powered, and main components include the console which includes electrical components and a touchscreen user interface, the IPL handpiece and cable, and a footswitch. The light pulses are emitted from the handpiece which is water cooled. The device is for prescription use only.

AI/ML Overview

The provided text does not include acceptance criteria for standalone device performance, nor details of a study that proves the device meets such criteria. In fact, point 7 of the document explicitly states: "A clinical study was not considered to be needed for this 510(k)." This indicates that no clinical performance study was conducted to demonstrate the device's effectiveness through a direct comparison against predefined acceptance criteria for clinical outcomes.

The document focuses on non-clinical testing and a substantial equivalence comparison to a predicate device (K161286) based on technical characteristics and indications for use.

Therefore, the requested information cannot be extracted from the provided text.

Here's an explanation of why each requested point cannot be answered:

A table of acceptance criteria and the reported device performance: Not provided. The document lists non-clinical tests (electrical safety, EMC, photobiological safety, biocompatibility) but does not state performance metrics or acceptance criteria for hair reduction effectiveness.
Sample size used for the test set and the data provenance: Not applicable, as no clinical study was performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was performed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as no clinical study was performed.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an Intense Pulsed Light (IPL) equipment, not an AI-powered diagnostic tool, and no clinical effectiveness study was conducted.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone clinical performance study was done to assess its effectiveness in hair reduction against specific clinical metrics.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no clinical study was performed.
The sample size for the training set: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.
How the ground truth for the training set was established: Not applicable, as no clinical study (and therefore no training set for a clinical algorithm) was performed.

The document focuses on demonstrating substantial equivalence to an existing legally marketed device (K161286), primarily through:

Non-clinical safety testing (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, ISO 10993-5, ISO 10993-10).
Comparison of technical specifications and indications for use.

The rationale for not needing a clinical study is implied by the concept of substantial equivalence, where the new device is sufficiently similar to a predicate device that has already demonstrated safety and effectiveness for similar indications.

Summary

{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".

August 12, 2022

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

Re: K220385

Trade/Device Name: Intense Pulsed Light Equipment 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: February 9, 2022 Received: February 10, 2022

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 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); 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 Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K220385

Device Name US 500 Intense Pulsed Light Equipment

Indications for Use (Describe)

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)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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.

1. Date of Preparation:2022/08/12
1. Sponsor Identification

Beijing Globalipl Development Co., Ltd.

F-8 Qunyinghui Building, Jinyuan Rd.32, Daxing Economic Development Zone, Beijing, China 102628

Contact Person: Liu Jun Position: QA Manager Tel: +86-15169727366 Fax: +86-10-60212336 Email:register@globalipl.com

1. 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, 102401, China

Tel: +86-18910677558 Fax: +86-10-56335780 Email: ray.wang@believe-med.com

{4}------------------------------------------------

4. Identification of Proposed Device

Trade Name: Intense Pulsed Light Equipment

Common Name: Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

Regulatory Information

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

Indication For Use Statement:

The US 500 Intense Pulsed Light Equipment is indicated for use in surgical and aesthetic applications in permanent hair reduction. 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:

న. Identification of Predicate Device(s)
510(k) Number: K161286 Product Name: IPL Therapy Machine Manufacturer: Beijing ADSS Development Co., Ltd

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards:

IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance.
A EC 60601-1-2:2014, Medical Electrical Equipment-Part 1-2: General Requirements For Basic Safety And Essential Performance Collateral Standard: Electromagnetic Compatibility-Requirements And Tests

{5}------------------------------------------------

IEC 60601-2-57:2011, 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
IEC 62471:2006 Photobiological safety of lamps and lamp system
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.
1. Clinical Test Conclusion

A clinical study was not considered to be needed for this 510(k).

1. Substantially Equivalent (SE) Comparison

Item	Proposed Device	Predicate Device	Remark
Device Name	Intense Pulsed LightEquipment	IPL Therapy Machine	/
ClassificationRegulation	21 CFR 878.4810	21 CFR 878.4810	SAME
Classification Panel	General & PlasticSurgery	General & PlasticSurgery	SAME
Class	II	II	SAME
Product Code	ONF	ONF	SAME
Common Name	Powered Light Based Non-LaserSurgical Instrument With Thermal Effect	Powered Light Based Non-Laser Surgical Instrument With Thermal Effect	SAME
Indication for use	The US 500 Intense PulsedLight Equipment is indicatedfor use in surgical and aestheticapplications in permanent hairreduction. Permanent hairreduction is defined as thelong-term, stable reduction inthe number of hairs regrowingwhen measured at 6, 9, and 12months after the completion ofa treatment regimen.	The VE2000 device is indicatedfor use in surgical, aestheticapplications in permanent hairreduction, reduction of benignpigmented lesions and benignvascular lesions.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9,and 12 months after thecompletion of a treatmentregimen.	SIMILARThe subsetindicationfor use forhairreductionis the same

Table 6-1 General Comparison

{6}------------------------------------------------

ITEM	Proposed Device	Predicate Device	Remark
Light source	Intense pulsed light	Intense pulsed light	SAME
Wavelength	640nm-1200nm,	480nm – 1200nm;590nm – 1200nm;640nm – 1200nm	SIMILAR
Deliver system	Sapphire	Sapphire	SAME
Energy density	1-40J/cm²	1-50J/cm²	SIMILAR
Pulse Width	1.0-9.9ms, adjustable	1-25ms	SIMILAR
Pulse Interval	1 – 99 ms	1 – 50 ms	SIMILAR
Light outputinterval	1 – 4 s	1 – 4 s	SAME
Pulse Number	1 - 6	1-6	SAME
Max. Power	2200VA	2200VA	SAME
Spot size	15 x 50mm	12 x 30 mm	SIMILAR
Cooling mode	close-cycle water cooling+ airContact cooling	Compressor closed circuit waterchiller with integrated heatexchanger.	SIMILAR
Power supply	AC 110/230V 50/60Hz	110V, 50Hz	SIMILAR

Table 6-2 Performance Comparison

9. Conclusion

The US500 Intense Pulse Light Equipment proposed device in this 510(k) uses the same IPL technology that is used in the predicate device K161286. Differences between the proposed device and predicate device do not raise new types of questions regarding safety and effectiveness, and performance testing demonstrates that the proposed device can be used safely and effectively for the proposed indications for use. The proposed US500 Intense Pulse Light Equipment device is considered to be substantially equivalent to the predicate K161286 device.

Regulation Number and Section

§ 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.