M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.

Device Description

The EnergyLounger, Model: TY-01 a device designed similar to a recliner, with 1260 LED lights, a switch for power on/off, and it can automatically stop treatment after 20 minutes use for M1/M2 and after 30 minutes use for M3, 2 buttons for mode selection, and an AC power supply for power supply.

The LED in the EnergyLounger, Model: TY-01 is a 1W imitation current light. It's a 4-in-1 LED, including 630nm, 630nm, 850nm and 940nm.The EnergyLounger, Model: TY-01 includes a detailed Instruction Manual, operators need to read the instructions carefully before use.

This device uses three types of LEDs and has three working modes, which can be selected by the user by pressing a button.

The device consists of an Energy Lounger, power cable, Product protect cover, Reflector, Goggles and User Manual.

AI/ML Overview

I'm sorry, but this document does not contain the detailed information necessary to entirely fulfill your request. The provided text is a 510(k) premarket notification letter and a 510(k) summary for a medical device called "EnergyLounger (TY-01)".

While it discusses the device's indications for use, its comparison to predicate devices, and non-clinical tests performed (electrical safety, EMC, biocompatibility, usability validation), it explicitly states:

"Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively."

This means there was no clinical study, human reader study, or establishment of ground truth regarding clinical outcomes (e.g., reduction of hip/waist circumference, treatment of wrinkles, pain relief) performed for this submission. Therefore, I cannot provide information on:

A table of acceptance criteria and reported device performance related to clinical effectiveness. The acceptance criteria mentioned are for non-clinical aspects like electrical safety and biocompatibility.
Sample size used for the test set (clinical).
Number of experts used to establish ground truth for the test set.
Adjudication method for the test set.
MRMC comparative effectiveness study.
Standalone (algorithm only) performance.
Type of ground truth used (clinical outcomes/pathology).
Sample size for the training set (clinical data).
How ground truth for the training set was established.

The document focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical safety/performance standards, rather than direct clinical efficacy trials.

However, I can extract information about the non-clinical acceptance criteria and tests:

1. A table of acceptance criteria and the reported device performance (Non-Clinical):

Acceptance Criteria Category	Specific Acceptance Criteria (Standards Met)	Reported Device Performance
Electrical Safety	IEC 60601-1:2020-08 Edition 3.2 (General requirements for basic safety and essential performance)	Complied with standards. (Note 1 indicates slight power supply differences were justified)
Home Healthcare Env. Safety	IEC 60601-1-11 Edition 2.1:2020-07 (Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment)	Complied with standards.
Non-Laser Light Source Safety	IEC 60601-2-57 Edition 1.0:2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment)	Complied with standards.
Electromagnetic Compatibility	IEC 60601-1-2 Edition 4.1:2020-09 (Electromagnetic disturbances - Requirements and tests)	Complied with standards.
Photobiological Safety	IEC 62471 First edition 2006-07 (Photobiological safety of lamps and lamp systems)	Complied with standards. (Note 2 regarding wavelengths was justified by this standard)
Biocompatibility - Cytotoxicity	ISO 10993-5 (In Vitro Cytotoxicity)	Biocompatible for intended use; complied with standard.
Biocompatibility - Sensitization	ISO 10993-10 (Skin Sensitization)	Biocompatible for intended use; complied with standard.
Biocompatibility - Irritation	ISO 10993-23 (Irritation reactivity)	Biocompatible for intended use; complied with standard.
Usability	IEC 62366-1 and IEC 60601-1-6	Complied with standards.

Regarding the other points, as stated above, the document explicitly indicates that no clinical testing was performed or needed for this 510(k). Therefore, questions related to clinical test sets, ground truth establishment for clinical outcomes, or human reader studies cannot be answered from this document.

Summary

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March 3, 2025

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra Official Correspondent Building#3 and Building#5. 40th of Fuxin Street. Huaide Community Fuyong Town, Baoan District Shenzhen, Guangdong 518103 China

Re: K241947

Trade/Device Name: EnergyLounger (TY-01) 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: OHS, OLI, ILY Dated: July 1, 2024 Received: July 3, 2024

Dear Alain Dijkstra:

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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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 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-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 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-device-advicecomprehensive-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-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-regulatory

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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: 2025.03.03 17:11:12
-05'00'

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

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Indications for Use

510(k) Number (if known) K241947

Device Name EnergyLounger, model: TY-01

Indications for Use (Describe)

M1 is used to reduce the circumference of the hips, waist and is indicated for use as a noninvasive dermatological.

M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary for K241947

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.

1. Submitter's Information

Sponsor Name: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: requlation@kaiyanmedical.com

Application Correspondent:

Contact Person: Alain Dijkstra Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com Date Prepared: Febuary 10, 2025

2. Subject Device Information:

Trade Name: EnergyLounger, model: TY-01 Classification Name: Light based over the counter wrinkle reduction Lamp, Infrared, Therapeutic Heating Fat Reducing Low Level Laser Review Panel: General & Plastic Surgery Product Code: OHS, ILY, OLI Regulation Number: 21 CFR 878.4810, 21 CFR 890.5500, 21CFR 878 5400 Regulation Class: II

3. Predicate Device Information Predicate Device 1 (K153399)

Sponsor: LED Intellectual Properties, LLC Trade Name: LightStim Professional LED Bed Classification Name: Infrared Lamp, Therapeutic Heating Review Panel: Physical Medicine Product Code: ILY Requlation Number: 21 CFR 890.5500 Regulation Class: II

Predicate Device 2 (K232977)

Sponsor: Biophotas Inc Trade Name: Biophotas Celluma CONTOUR Classification Name: Light based over the counter wrinkle reduction Review Panel: General & Plastic Surgery Product Code: OLI, ILY, OHS

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Regulation Number: 21 CFR 878.5400, 21 CFR 890.5500, 21 CFR 878.4810 Regulation Class: II

Predicate Device 3 (K223147)

Sponsor: MyBlend Trade Name: MyLedMAsk Classification Name: Light based over the counter wrinkle reduction Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II

4. Device Description

This device uses three types of LEDs and has three working modes, which can be selected by the user by pressing a button.

The device consists of an Energy Lounger, power cable, Product protect cover, Reflector, Goggles and User Manual.

5. Intended Use / Indications for Use

M1 is used to reduce the circumference of the hips, waist and is indicated for use as a noninvasive dermatological.

M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles.

6. Comparison to predicate devices

Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.

Elements ofComparison	Subject device	Predicate device(K153399)	Predicate device(K232977)	Predicate device(K223147)	Remark
Company	Shenzhen KaiyanMedical EquipmentCo., Ltd	LED IntellectualProperties LLC	BiophotasCellumaCONTOUR	MyBlend	--
Elements ofComparison	Subject device	Predicate device(K153399)	Predicate device(K232977)	Predicate device(K223147)	Remark
Trade Name	EnergyLounger	LightStimProfessional LedBed	BiophotasCellumaCONTOUR	MyLedMAsk	--
Model	TY-01	N/A	N/A	N/A	--
510 (K) Number	K241947	K153399	K232977	K223147	--
RegulationClass	Class II	Class II	Class II	Class II	Same
Indications forUse / Intendeduse	M1 is used toreduce thecircumference ofthe hips, waist andthighs and isindicated for use asa non-invasivedermatological.M2 is intended toemit energy in thevisible and infraredregion of thespectrum for use inthe treatment offull-face wrinkles.M3 is intended toemit energy in thevisible and IRspectrum intendedto provide topicalheating for thepurpose ofelevating tissuetemperature for atemporary relief ofminor muscle andjoint pain andstiffness, minorarthritis.pain or musclespasm, thetemporary increasein local bloodcirculation, and the	The LightStimProfessional LEDBed is an over-the-counter deviceintended to emitenergy in thevisible and IRspectrum intendedto provide topicalheating for thepurposeof elevating tissuetemperature for atemporary relief ofminor muscle andjoint pain andstiffness, minorarthritis pain ormuscle spasm,the temporaryincrease in localbloodcirculation, andthe temporaryrelaxation ofmuscles.	The BIOPHOTASCellumaCONTOUR isindicated for useas a non-invasivedermatologicalaesthetictreatment for thereduction ofcircumference ofhips, waist, andthighs.The BIOPHOTASCellumaCONTOUR isintended to deliverheat in the nearinfra-red spectrumto provide topicalheating for thepurpose ofelevating tissuetemperature; forthe temporaryrelief of minormuscle and jointpain, arthritis,and musclespasm; relievingstiffness;promoting the	MyLedMask is anover-thecounterdevice that isintendedto emit energy inthe visibleand infrared regionof thespectrum for use inthetreatment of full-face wrinkles	Same
Elements ofComparison	Subject device	Predicate device(K153399)	Predicate device(K232977)	Predicate device(K223147)	Remark
	temporaryrelaxation ofmuscles.		relaxation ofmuscle tissue; andto temporarilyincrease localbloodcirculation.The BioPhotasCellumaCONTOUR isintended to emitenergy in thevisible andinfrared region ofthe spectrum forusein the treatment offull-face wrinkles.
Power Source	Input: 100-240Vac50/60Hz, 30.5A/115Vac,16A/230VacOutput: 12Vdc,240A	Unpublished	90-264 VAC	Voltage: 100 to240 volts, ACFrequency:50-60HzIntensity: 0.35 A	Different,note 1
Wavelengths	630nm, 850nm,940nm	630nm, 660nm,855nm, 940nm	Red: 640nm +/-25nm880nm +/- 50nm	Red: 630 nm(OSRAM LS T67F)NIR: 850 nm(OSRAM SFH4253)	Similar,note 2
Irradiancesource	LED	LED	LED	LED	Same
LED number	1260	18240	Unpublished	Total 288 LEDs- 144 for 630 nmand 144 for850 nm- 244 for the face	Differentnote3
Elements ofComparison	Subject device	Predicate device(K153399)	Predicate device(K232977)	Predicate device(K223147)	Remark
				and 44 for theneck
Intendedlocation Use	Full body	Full body	Full body	Full Face and neck	Same
Irradiance(mW/cm²)	M1 (630nm): 4.2mw/cm²M2(630nm+850nm):18.7 mw/cm²M3(630+850+940nm):60 mw/cm²	60 mW/cm 2	640nm -4.2mW/cm 2880nm -0.7mW/cm2	18.7 mW/cm²(average of 6measurementlocation (includingone on theneck) between 10to 27mW/cm²)	Same
LED distribution	Uniform distribution	Uniformdistribution	Uniformdistribution	Uniform distribution	Same
Treatment Time	M1: 20minM2: 20minM3: 30min	5-30 min	30min	According to skinphototype,daily- 1 fair skin: 5 min35 (335 s)- 2 moderately darkskin: 11min 10 (670 s)- 3 dark skin: 13min 55 (835 s)during 6 to 8weeks	Same

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Comparison in Detail(s):

Note 1 : Although the "Power Supply" is a little different from the predicate devices, they all complied with the IEC 60601-1, and IEC 60601-1-2 series safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.

Note 2: Although the "Wavelengths" is a little different from the predicate devices, but wavelengths of the subject device can be covered by the predicate device. Due to the characteristics of LED lights, the

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emission parameters are showing the peak wavelength of the lamp, and have been assessed by IEC 62471, So, these slight differences will not raise any safety or effectiveness issues.

Note 3: Although the "Number of LEDs" is different from the predicate devices, but the safety and performance are depend on the Irradiance, so the number of LEDs will not raise any safety or effectiveness issues.

7. Test Summary

7.1 Non-Clinical Tests Performed

1) Electrical safety, and electromagnetic compatibility Test

Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:

IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment Part 1: General requirements for basic ﻬ safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment Part 1: 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 Edition 1.0 2011-01 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 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests.
� IEC 62471 First edition 2006-07 Photobiological safety of lamps and lamp systems.

2) Biocompatibility Test

The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (In Vitro Cytotoxicity), ISO 10993-10 (Skin Sensitization) and ISO 10993-23 (Irritation reactivity).

3) Usability validation

Usability testing was conducted on the EnergyLounger (Models: TY-01), which complies with IEC 62366-1 and IEC 60601-1-6.

7.2 Summary of Clinical Performance

Clinical testing was not needed for this 510(k). The non-clinical performance testing described above is sufficient to support that the device can be used safely and effectively.

8. Date of the summary prepared: February 10, 2025

9. Final Conclusion

The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devicesK153399, K223147 and K232977.

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.