Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

Device Description

Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL) with safety and efficacy. It is designed with a lamp that can emit continuously double or triple pulses per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain and nearly heatless.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the "Ice Cooling IPL Hair Removal Device" describe a medical device submission and its review. However, it does not contain the specific information required to describe acceptance criteria and associated study results for an AI/ML-based medical device.

The document primarily focuses on:

Regulatory classification and product codes: Identifying the device as Class II, Product Code OHT, under 21 CFR 878.4810.
Intended use: Hair removal and permanent reduction in hair regrowth.
Comparison to predicate devices: Demonstrating substantial equivalence in terms of intended use, design, specifications, and performance (e.g., wavelength range, energy density, spot size).
Performance data (Non-Clinical): Referring to biocompatibility testing, electrical safety (EMC), light safety, software verification and validation (not AI-specific performance), and usability testing, all against established industry standards (IEC, ISO).

Crucially, there is no mention of:

AI/ML components: The device is described as an Intense Pulsed Light (IPL) device, and its operation does not inherently involve AI/ML. "Software Verification and Validation" is a standard requirement for electronic medical devices and does not imply AI.
Clinical study data for performance metrics: The performance data section refers only to non-clinical tests (biocompatibility, electrical safety, light safety, software V&V, usability). It does not provide details on clinical efficacy (hair reduction) studies with specific performance metrics, sample sizes, or ground truth establishment relevant to the device's hair removal claim. The "permanent reduction in hair regrowth" indication implies clinical testing, but the details are not present in this summary.
Expert consensus, MRMC studies, or specific AI performance metrics like sensitivity, specificity, AUC: These are typical elements of a study proving an AI device meets acceptance criteria.

Therefore, it is not possible to fill in the requested table and answer the questions based solely on the provided text, as the device described is not an AI/ML medical device, and the document focuses on non-clinical substantial equivalence rather than detailed clinical performance of the hair removal efficacy.

Hypothetical Example (if this were an AI/ML device and the text provided the necessary details):

If, for instance, the device had an AI component to detect skin type or predict hair regrowth, and the document detailed a study on this AI component, the information could be extracted like this (this is purely illustrative and not based on the provided text):

Hypothetical Acceptance Criteria and Study for an AI-Powered Hair Removal Device

Let's imagine this device also had an AI feature, for example, an integrated AI system that analyzes skin pigmentation to recommend optimal IPL settings to minimize adverse events and maximize efficacy.

1. A table of acceptance criteria and the reported device performance

Performance Metric	Acceptance Criteria	Reported Device Performance
AI Module: Skin Type Classification Accuracy	>95% accuracy for Fitzpatrick Skin Types I-V	96.2% overall accuracy
Sensitivity (Fitzpatrick IV)	>90%	91.5%
Specificity (Fitzpatrick IV)	>90%	93.8%
AI Module: Optimal Setting Recommendation (Safety)	< 1% incidence of moderate-to-severe adverse skin reactions (burns, hyperpigmentation) when AI-recommended settings are followed	0.8% incidence of moderate-to-severe adverse skin reactions
AI Module: Optimal Setting Recommendation (Efficacy)	>50% hair reduction at 6 months when AI-recommended settings are followed, across Fitzpatrick Skin Types I-V	58% average hair reduction at 6 months

2. Sample size used for the test set and the data provenance

AI Skin Type Classification Test Set: 1500 images/cases (1000 for training, 500 for validation/testing).
Adverse Event/Efficacy Test Set (Clinical Trial): 300 participants.
Data Provenance:
- Skin images for AI classification: Retrospective dataset collected from dermatology clinics in North America (USA, Canada) and Europe (UK, Germany).
- Clinical trial for adverse events/efficacy: Prospective, multi-center, randomized controlled trial conducted in the USA (5 sites) and China (3 sites).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Skin Type Ground Truth: 3 board-certified dermatologists, each with a minimum of 10 years of experience in aesthetic dermatology and laser/IPL treatments. All were trained to consistently apply Fitzpatrick Skin Type scale.
Adverse Event/Efficacy Ground Truth: Clinical investigators (dermatologists) at each trial site, with at least 5 years of experience in IPL/laser treatments, reviewed and graded adverse events and hair reduction independently at follow-up visits.

4. Adjudication method for the test set

Skin Type Ground Truth: For the AI classification test set, initial skin type labels were provided by one expert. For any ambiguous cases (e.g., initial disagrement or boundary cases), a 3-expert consensus (2+1 majority rule) was used. If a consensus was not reached (e.g., 1-1-1 split), the case was excluded from the ground truth set.
Adverse Event/Efficacy Ground Truth: For clinical trial outcome adjudication, two independent, unblinded dermatologists graded outcomes (hair reduction percentage, adverse events) at each follow-up visit. In case of discrepancy, a third blinded dermatologist acted as an adjudicator to reach a consensus.

5. 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

Yes, an MRMC study was performed to assess the impact of AI-recommended settings vs. manual-expert settings on clinical outcomes.
Study Design: 10 IPL therapists/dermatologists (readers) were recruited. They each reviewed 50 simulated patient profiles (cases) and recommended IPL settings.
- Group A (without AI): Readers used standard clinical guidelines and their experience.
- Group B (with AI assistance): Readers were provided with the AI system's recommended settings and could choose to accept, modify, or reject them.
Effect Size: The AI-assisted group (Group B) demonstrated a statistically significant improvement in the rate of optimal setting selection (leading to good outcomes without adverse events) by 15% (Cohen's d = 0.65) compared to the unassisted group (Group A). Specifically, the rate of selecting optimal, safe, and effective settings increased from 70% (unassisted) to 85% (AI-assisted).

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, a standalone performance evaluation of the AI skin type classification module was conducted prior to its integration into the device and the MRMC study. This included the accuracy, sensitivity, and specificity metrics mentioned in section 1.

7. The type of ground truth used

Expert Consensus: For skin type classification (AI module training and testing).
Clinical Outcomes Data: For validating the safety and efficacy of AI-recommended settings (adverse event rates, hair reduction percentage from prospective clinical trial data).

8. The sample size for the training set

AI Skin Type Classification: 15,000 unique skin images with associated Fitzpatrick Skin Type labels.

9. How the ground truth for the training set was established

The ground truth for the training set was established by three experienced board-certified dermatologists, similar to the test set experts. Each image was independently reviewed and labeled by all three. If discrepancies occurred, a consensus process involving discussion and re-evaluation was used to arrive at a final label. This iterative process ensured high-quality, reliable ground truth data for training the AI model.

Summary

FDA 510(k) Clearance Letter - Ice Cooling IPL Hair Removal Device

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 24, 2025

Shenzhen Ulike Smart Electronics Co.,Ltd.
Yang Blue
Registration Director
810, Bldg 1, Xunmei Science and Tech Plaza, No. 8
Keyuan Rd, Science Pk Cmty Yuehai Sub-Dist. Nanshan Dist
Shenzhen, Guangdong 518000
China

Re: K251984
Trade/Device Name: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)
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: June 27, 2025
Received: June 27, 2025

Dear Yang Blue:

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 (the 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 available 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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2K251984 - Yang Blue Page

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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3K251984 - Yang Blue Page

assistance/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,

YAN FU -S
Digitally signed by YAN FU -S
Date: 2025.07.24 12:48:22 -04'00'

for Tanisha Hithe
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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251985

Device Name: Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

Indications for Use (Describe):
Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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 regime.

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)

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
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"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."

Page 5

510(k) Summary of K251984

I. Submitter

Shenzhen Ulike Smart Electronics Co.,Ltd.
Address: 810, Building 1, Xunmei Science and Technology Plaza, No. 8 Keyuan Road, Science Park Community, Yuehai Sub-District, Nanshan District, Shenzhen 518000, Guangdong, P.R. China
Contact person: Blue Yang
Email: blue@ulike.com
The date the summary was prepared: 6/27/2025

II. Device

Name of Device: Ice Cooling IPL Hair Removal Device
Model(s): UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU
Common or Usual Name: Light Based Over-The-Counter Hair Removal
Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
Regulatory Class: II
Product Code: OHT
Regulation Number: 21 CFR 878.4810

III. Device Description

Page 6

The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable and safer experience.

IV. Indications for Use

V. Comparison of Technological Characteristics With the Predicate Device

The Ice Cooling IPL Hair Removal Device has the same intended use and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices. Ice Cooling IPL Hair Removal Device is compared with the following legally marketed devices in terms of intended use, design, specifications and performance:

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
510(k) number	K251984	K250194	K230122	K221002	/
Trade Name	Ice Cooling IPL Hair Removal	Ice Cooling IPL Hair Removal	IPL Hair Removal Device	IPL Hair Removal Device	/

Page 7

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
Device	Device
Manufacturer	Shenzhen Ulike Smart Electronics Co., Ltd.	Shenzhen Ulike Smart Electronics Co., Ltd.	Shenzhen Ulike Smart Electronics Co., Ltd.	Shenzhen Ulike Smart Electronics Co., Ltd.	/
Regulation number	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810	Same
Product code	OHT	OHT	OHT	OHT	Same
Device classification	Class II	Class II	Class II	Class II	Same
Indication for use/Intended use	Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of	Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of	IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the	IPL Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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	Same

Page 8

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
	hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.	hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.	completion of a treatment regime.	treatment regime.
Prescription or OTC	OTC	OTC	OTC	OTC	Same
Applicable skin	Fitzpatrick Skin Types I-V	Fitzpatrick Skin Types I-V	Fitzpatrick Skin Types I-V	Fitzpatrick Skin Types I-V	Same
Treatment area	Large areas (e.g. arms, legs, chest) and small areas (e.g. lip)	Large areas (e.g. arms, legs, chest) and small areas (e.g. lip)	Large areas (e.g. arms, legs, chest) and small areas (e.g. lip)	Large areas (e.g. arms, legs, chest) and small areas (e.g. lip)	Same
Device design
Source energy	Supplied by external adapter	Supplied by external adapter	Supplied by external adapter	Supplied by external adapter	Same
Power supply	100-240V~, 50/60Hz	100-240V~, 50/60Hz	100-240V~, 50/60Hz	100-240V~, 50/60Hz	Same
Dimension	179.058.237.2mm	179.058.237.2mm	60×38×170mm	60.5(W)x38(H)x169.7(L)mm	Same
Sterilization	Not required	Not required	Not required	Not required	Same
Output specification
Light source	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Intense Pulsed Light	Same

Page 9

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
Energy medium	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Xenon Arc Flashlamp	Same
Wavelength range	550nm-1200nm	550nm-1200nm	560-1200mm	550-1200mm	Same
Energy density	2.42-7.27J/cm²	UI06S PR,UI06S PN,UI06S WH: 2.42-7.27J/cm² UI06S PRU, UI06S PNU,UI06S WHU: 2.42-5.45J/cm²	2.42-7.27J/cm²	2.4-7.2J/cm²	3.03-5.3J/cm²
Output energy	8-24J	UI06S PR,UI06S PN,UI06S WH: 8-24J UI06S PRU, UI06S PNU,UI06S WHU: 8J~18J	8-24J	9.9~19.8J	10.0~17.5J
Spot size	3.3cm²	3.3cm²	3.3cm²	3.3cm²	Same
Pulse duration	1.82-8.07ms Multipulse	UI06S PR,UI06S PN,UI06S WH: 1.82-8.07ms multipulse	1.15-6.2ms	7-10ms	Same

Page 10

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
		UI06S PRU, UI06S PNU,UI06S WHU: 1.82ms~7.09ms
Pulsing control	Finger switch	Finger switch	Finger switch	Finger switch	Same
Delivery device	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Direct illumination to tissue	Same
Output intensity level	4 levels	UI06S PR,UI06S PN,UI06S WH: 4 levels UI06S PRU, UI06S PNU,UI06S WHU: 3 levels	4 levels	5 Levels	5 Levels
Software/Firmware/Microprocessor Control?	Yes	Yes	Yes	Yes	Same
Additional features
Electrical safety	IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11	IEC 60601-1 IEC 60601-1-2 IEC 60601-1-11	ANSI AAMI ES 60601-1 IEC 60601-1-2	ANSI AAMI ES 60601-1 IEC 60601-1-2	Same

Page 11

Comparison Items	Subject Device	Predicate Device 1	Predicate Device 2	Predicate Device 3	Remark
	IEC 60601-2-57 IEC 60601-2-83	IEC 60601-2-57 IEC 60601-2-83	IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83	IEC 60601-1-11 IEC 60601-2-57 IEC 60601-2-83
Eye safety	IEC 62471	IEC 62471	IEC 62471	IEC 62471	Same
Biocompatibility	ISO 10993-5 ISO 10993-10 ISO 10993-23	ISO 10993-5 ISO 10993-10 ISO 10993-23	ISO 10993-5 ISO 10993-10	ISO 10993-5 ISO 10993-10	Same

VIII. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Summary of performance testing

The following performance data were provided in support of the substantial equivalence determination.

1) Biocompatibility Testing

The biocompatibility evaluation for the body-contacting components of the IPL Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993- 1, 'Biological Evaluation of Medical Devices–Part 1: Evaluation and Testing Within a Risk Management Process, Document", as recognized by FDA. The following testing was performed to, and passed, including:

ISO 10993-10:2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization
ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for irritation
ISO 10993-5: 2009, Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity

2) Electrical Safety and EMC

Page 12

Electrical safety and EMC testing was performed to, and passed, as per the following standards:

IEC 60601- 1:2005+A1:2012+A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601- 1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601- 1- 11:2015+A1:2020 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 the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
IEC 60601-2-83:2022 Medical electrical equipment - Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment

3) Light Safety

IEC 62471:2006 Photobiological safety of lamps and lamp systems

4) Software Verification and Validation

Software documentation consistent with Basic Documentation Level was submitted in this 510(k). System 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.

5) Usability

The product usability has been evaluated and validated according to the following standard and FDA guidance.

IEC 60601-1-6:2005+2012+2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016

Conclusion: Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device Ice Cooling IPL Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate devices.

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.