The IPL Hair Removal Device is a light-based device and an over-the-counter device which is expected to be sold directly to end users. The device provides hair reduction using Intense Pulsed Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. 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 has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) 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), it will cannot emit the treatment light pulses.

AI/ML Overview

This appears to be a 510(k) summary for an IPL Hair Removal Device (Model: BZ-0721) submitted to the FDA. The document focuses on demonstrating substantial equivalence to a predicate device (IPL Home Use Hair Removal Device, Model: D-1128, K192432) rather than providing detailed acceptance criteria and a study to prove meeting those criteria in the manner one might find for a novel diagnostic or AI-driven device.

Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:

Acceptance Criteria and Reported Device Performance

Since this is a substantial equivalence submission for an IPL hair removal device, the "acceptance criteria" are primarily related to safety standards and comparability to the predicate device. There aren't specific performance metrics like sensitivity or specificity associated with an AI diagnostic. Instead, the performance is demonstrated by meeting recognized safety and electrical standards and showing that key technical specifications are either the same or comparable, without raising new questions of safety or effectiveness.

Acceptance Criterion (Type)	Reported Device Performance (Subject Device: IPL Hair Removal Device, Model BZ-0721)
Electrical Safety	Passed ANSI AAMI ES60601-1:2005/(R)2012 (and amendments), IEC 60601-1-11:2015, IEC 60601-2-57:2011
Electromagnetic Compatibility	Passed IEC 60601-1-2:2014
Biocompatibility	Passed ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and skin sensitization)
Photobiological Safety	Passed IEC 62471:2006
Software Verification & Validation	Documentation consistent with moderate level of concern, system validation testing demonstrated all software requirement specifications met and hazards mitigated.
Wavelength	510nm~1100nm (Comparable to Predicate: Regular window: 510-1100nm, Filter window: 600-1100nm)
Energy Density	1.5-3.0 J/cm² (Comparable to Predicate: 2.0-4.0 J/cm²)
Spot Size	4cm² (Comparable to Predicate: Regular window: 4.5cm², 2.0cm², 3.0cm²; Filter window: 2.5cm²)
Output Energy	6.0J ~ 11.8J (Comparable to Predicate: 4.0J ~ 18.0J)
Pulse Duration	10.4ms (Comparable to Predicate: 7.5~14ms)
Indications for Use	"The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair." (Same as Predicate)
Technology	Intense Pulsed Light (IPL) (Same as Predicate)
Energy Medium	Xenon lamp (Same as Predicate)

Missing Information (Not applicable or not typically included in this type of submission for this device category):

For this type of device (IPL hair removal), the concepts of "test set," "ground truth," "experts for ground truth," "adjudication," "MRMC study," "standalone performance," and "training set" are generally not applicable in the context of the provided documentation. These are typically associated with diagnostic devices, often AI-driven, where there is a "diagnosis" or "detection" task.

Here's why:

This is not an AI/diagnostic device. The device is an IPL hair removal device, demonstrating safety and performance primarily through engineering standards and comparison to a predicate, not through diagnostic accuracy metrics.
No clinical performance data. Section 8 explicitly states, "No new clinical performance data is reported in this submission." This indicates that a study demonstrating effectiveness (e.g., hair reduction percentage) was likely not part of this submission for the purpose of demonstrating substantial equivalence to the predicate, as the predicate itself likely established that effectiveness. The focus here is on proving the new device is as safe and performs similarly enough to the already-cleared predicate.

Therefore, the following information cannot be extracted from the provided text:

Sample size used for the test set and the data provenance: Not applicable as it's not a diagnostic device with a test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-assisted diagnostic device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

October 21, 2021

Zhongshan Bisen Plastic Electronic Products Co., Ltd. % Mark Leung Consultant Shenzhen Joyantech Consulting Co.,Ltd. 1713A, Block A, Zhongguan Times Square Liuxian Avenue, Xili Town Shenzhen, Guangdong 518000 China

Re: K212314

Trade/Device Name: IPL Hair Removal Device 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 Dated: July 16, 2021 Received: July 23, 2021

Dear Mark Leung:

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) K212314

Device Name IPL Hair Removal Device

Indications for Use (Describe)

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

Prescription Use (Part 21 CFR 801 Subpart D)

X 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}------------------------------------------------

Zhongshan Bisen Plastic Electronic Products Co., Ltd.

VOL_005_510(k) Summary 001_510(k) Summary

Product: IPL Hair Removal Device

Version: A/2

510(k) Summary

This summary of 510(K) safety and effectiveness information is submitted As Required by requirements of SMDA and 21 CFR §807.92.

1.	Administrative Information
----	----------------------------

Submission Date	July 16, 2021
Manufacturerinformation	Zhongshan Bisen Plastic Electronic Products Co., Ltd.
	Address:
	Second Floor, A Building, No.32 JianYe Road, Torch
	Development Zone
	Zhongshan City Guangdong, CN 528437.
	Contact person: Rao Guanhua
	TEL: +86(760)88297142
	E-Mail: 376299441@qq.com

SubmissionCorrespondent	Shenzhen Joyantech Consulting Co., Ltd.
	1713A, 17th Floor, Block A, Zhongguan Times Square, Liuxian
	Avenue, Xili Town, Nanshan District, Shenzhen, Guangdong
	Province, China.
	Contact person: Mr. Mark Leung; Mr. Field Fu
	E-Mail: mark_leung@cefda.com; field@cefda.com
	Image: logo

Establishmentregistration number	3010564031

2. Device Information

Type of 510(k)	Traditional
Submission:
Device Name:	IPL Hair Removal Device
Model:	BZ-0721
Classification Name:	Laser surgical instrument for use in general and plastic surgery
	and in dermatology
Review Panel:	General & Plastic Surgery
Device Class:	2
Regulation Number:	878.4810
Product Code:	OHT

1. Predicate Device

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

Zhongshan Bisen Plastic Electronic Products Co., Ltd.

VOL 005 510(k) Summary 001_510(k) Summary Version: A/2

Product: IPL Hair Removal Device

Manufacturer:	Shenzhen Bosidin Technology Co.,Ltd.
Device Name:	IPL Home Use Hair Removal Device
Model:	D-1128
510(K) Number:	K192432
Product Code:	OHT

Device Description 4.

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. The device has two working modes, an automatic mode and a manual mode. Each mode has 5 levels of output energy. The device contains a Xenon lamp that emits pulses of light (a total of 350000 pulses over the device's lifetime) 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), it will cannot emit the treatment light pulses.

5. Intended Use/Indications for Use

The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.

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

Zhongshan Bisen Plastic Electronic Products Co., Ltd.	VOL_005_510(k) Summary001_510(k) Summary
-------------------------------------------------------	----------------------------------------------

Product: IPL Hair Removal Device

Version: A/2

6. Comparison with predicate device

ID	ComparisonItems	Subject Device	Predicate Device (K192432)	Comparison
1	Device name	IPL Hair Removal Device	IPL Home Use Hair Removal Device	/
2	Model	BZ-0721	D-1128	/
3	ClassificationName	Laser surgical instrument for use in general and plasticsurgery and dermatology	Laser surgical instrument for use in general and plasticsurgery and dermatology	Same
4	Product Code	OHT	OHT	Same
5	RegulationNumber	878.4810	878.4810	Same
6	Class	II	II	Same
7	Prescription orOTC	OTC	OTC	Same
8	Indications forUse	The IPL Hair Removal Device is an over-the-counter deviceintended for removal of unwanted body and/or facial hair	IPL Home Use Hair Removal Device is an over-the-counterdevice intended for removal of unwanted body and/or facialhair.	Same
9	Source Energy	Supplied by external adapter	Supplied by external adapter	Same
10	Technology	Intense Pulsed Light (IPL)	Intense Pulsed Light (IPL)	Same
11	Energy medium	Xenon lamp	Xenon lamp	Same
12	Pulsing Control	Finger switch	Finger switch	Same
13	Delivery device	Direct illuminationto tissue	Direct illuminationto tissue	Same
ID	Comparison Items	Subject Device	Predicate Device (K192432)	Comparison
14	Wavelength	510nm~1100nm	Regular window: 510-1100nmFilter window: 600-1100nm	Comparable(1) See below
15	Energy density	1.5-3.0 J/cm²	2.0~4.0J/cm²	Comparable(2) See below
16	Spot Size	4cm²	Regular window: 4.5cm², 2.0cm², 3.0cm²Filter window:2.5cm²	Comparable(3) See below
17	Output energy	6.0J ~ 11.8J	4.0J ~ 18.0J	Comparable(4) See below
18	Pulse duration	10.4ms	7.5~14ms	Comparable(5) See below
19	Weight	333g	Unknown	Comparable(6) See below
20	Dimension	169.0x81.0x197.0mm (H x W x D)	Unknown	Comparable(6) See below
21	Applicablestandards	ANSI AAMI 60601-1IEC 60601-1-11IEC 60601-1-2IEC 60601-2-57ISO 10993-5ISO 10993-10	IEC 60601-1IEC 60601-1-11IEC 60601-1-2IEC 60601-2-57ISO 10993-5ISO 10993-10	Same
ID	ComparisonItems	Subject Device	Predicate Device (K192432)	Comparison
		IEC 62471	IEC 62471

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

Zhongshan Bisen Plastic Electronic Products Co., Ltd.

VOL_005_510(k) Summary 001_510(k) Summary

Product: IPL Hair Removal Device

Version: A/2

{7}------------------------------------------------

Zhongshan Bisen Plastic Electronic Products Co., Ltd.

VOL_005_510(k) Summary 001 510(k) Summary

Product: IPL Hair Removal Device

Version: A/2

Note:

(1) Wavelength:

The wavelength range differences between the subject and predicate device do not raise new concerns of safety and effectiveness for the power output levels.

(2) Energy density:

The energy density range differences between the subject and predicate device of safety and effectiveness. The energy density is the amount of light energy delivered per unit area. The energy density range is calculated according to the following formula:

Output energy (J) ---------Formula 1 Energy density(J/cm2) = Spot Size (cm2)

(3) Spot Size:

For the output spot size, there is a minor difference between the precicate device. The spot size differences between the subject and predicate devices do not raise new concerns of safety and effectiveness.

{8}------------------------------------------------

Zhongshan Bisen Plastic Electronic Products Co., Ltd.	VOL_005_510(k) Summary001_510(k) Summary
Product: IPL Hair Removal Device	Version: A/2

(4) Output energy:

The energy density is the amount of light energy delivered per unit area. According formula, the output energy can be calculated.

Output energy (J)= Energy density(J/cm2) × Spot Size (cm2) -------------Formula 2

The output energy range of predicate device is 4.0-18.0. The output energy of subject device. The output energy differences between the subject and predicate devices do not raise new concerns of safety and effectiveness.

(5) Pulse duration:

The pulse duration range of subject device is within the range of predicate device. The pulse the subject and predicate devices do not raise new concerns of safety and effectiveness.

(6) Weight and Dimension:

The weight and dimension differences between subject and predicate devices do not raise new concerns of safety and effectiveness.

{9}------------------------------------------------

Product: IPL Hair Removal Device

7. Non-Clinical Test Summary

7.1. Electromagnetic Compatibility and Electrical Safety Test

The subject device has passed safety and performance testing in according to following standards.

ANSI AAMI ES60601-1:2005/(R)2012 and 1) A1:2012, C1:2009/(R)2012 and A2:2010/(R)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 2) basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1. IEC 60601-1-11:2015 Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-2-57:2011 Medical Electrical Equipment Part 2-57: Particular requirements for 4) the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
1. IEC 62471:2006 Photobiological safety of lamps and lamp systems

7.2. Biocompatibility Test

The subject device has passed biocompatibility tests in according to following standards.

ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro 1) cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

7.3. Software Verification and Validation

Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

8. Clinical Study

No new clinical performance data is reported in this submission.

9. Conclusion

The technological characteristics and indications for the subject device (IPL Hair Removal Device [Model: BZ-0721]) do not raise new types of questions regarding safety and effectiveness when compared to the predicate device (K192432). Based on its

{10}------------------------------------------------

Zhongshan Bisen Plastic Electronic Products Co., Ltd.	VOL_005_510(k) Summary001_510(k) Summary
Product: IPL Hair Removal Device	Version: A/2

technical characteristics, design, functional features, performance test data, and its indications for use as listed above, the subject device is considered to be substantially equivalent to the predicate 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.