(243 days)
Not Found
No
The device description and intended use focus on the emission of light energy for therapeutic purposes. There is no mention of AI, ML, image processing, or any data-driven decision-making or analysis within the device's functionality. The operation is based on user selection of modes and automated timers.
Yes
The device is described as being used for the "treatment" of full-face wrinkles (M2), and for "relief" of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, and "increase" in local blood circulation (M3), all of which indicate a therapeutic purpose.
No
The device is intended for therapeutic uses such as reducing circumference, treating wrinkles, and providing temporary relief from pain and stiffness, not for diagnosing conditions.
No
The device description clearly outlines physical hardware components such as LED lights, a power switch, mode selection buttons, an AC power supply, and the lounger structure itself. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Function: The EnergyLounger, Model: TY-01 is a device that emits light energy (LEDs) for therapeutic purposes applied externally to the body (skin).
- Intended Use: The intended uses described (reducing circumference, treating wrinkles, relieving pain, increasing circulation, relaxing muscles) are all related to external physical effects on the body, not the analysis of biological samples.
- Device Description: The description focuses on the physical design, light sources, and operational modes, not on components or processes related to sample collection or analysis.
- Lack of IVD Indicators: There is no mention of sample collection, reagents, analytical methods, or any other elements typically associated with in vitro diagnostics.
Therefore, the EnergyLounger, Model: TY-01 falls under the category of a therapeutic device that uses light energy, not an in vitro diagnostic device.
N/A
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.
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.
Product codes (comma separated list FDA assigned to the subject device)
OHS, OLI, ILY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
hips, waist (M1); full-face (M2); Not Specified (M3, for topical heating for muscle/joint pain, stiffness, arthritis, muscle spasm)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 safety and essential performance
- 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.
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).
Usability validation: Usability testing was conducted on the EnergyLounger (Models: TY-01), which complies with IEC 62366-1 and IEC 60601-1-6.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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.
1
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
2
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
3
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.
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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
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
5
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
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.
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.
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.
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 of
Comparison | Subject device | Predicate device
(K153399) | Predicate device
(K232977) | Predicate device
(K223147) | Remark |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Company | Shenzhen Kaiyan
Medical Equipment
Co., Ltd | LED Intellectual
Properties LLC | Biophotas
Celluma
CONTOUR | MyBlend | -- |
| Elements of
Comparison | Subject device | Predicate device
(K153399) | Predicate device
(K232977) | Predicate device
(K223147) | Remark |
| Trade Name | EnergyLounger | LightStim
Professional Led
Bed | Biophotas
Celluma
CONTOUR | MyLedMAsk | -- |
| Model | TY-01 | N/A | N/A | N/A | -- |
| 510 (K) Number | K241947 | K153399 | K232977 | K223147 | -- |
| Regulation
Class | Class II | Class II | Class II | Class II | Same |
| Indications for
Use / Intended
use | M1 is used to
reduce the
circumference of
the hips, waist and
thighs and is
indicated for use as
a non-invasive
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.
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 | The LightStim
Professional LED
Bed is an over-
the-counter device
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. | The BIOPHOTAS
Celluma
CONTOUR is
indicated for use
as a non-invasive
dermatological
aesthetic
treatment for the
reduction of
circumference of
hips, waist, and
thighs.
The BIOPHOTAS
Celluma
CONTOUR is
intended to deliver
heat in the near
infra-red spectrum
to provide topical
heating for the
purpose of
elevating tissue
temperature; for
the temporary
relief of minor
muscle and joint
pain, arthritis,
and muscle
spasm; relieving
stiffness;
promoting the | MyLedMask is an
over-thecounter
device that is
intended
to emit energy in
the visible
and infrared region
of the
spectrum for use in
the
treatment of full-
face wrinkles | Same |
| Elements of
Comparison | Subject device | Predicate device
(K153399) | Predicate device
(K232977) | Predicate device
(K223147) | Remark |
| | temporary
relaxation of
muscles. | | relaxation of
muscle tissue; and
to temporarily
increase local
blood
circulation.
The BioPhotas
Celluma
CONTOUR is
intended to emit
energy in the
visible and
infrared region of
the spectrum for
use
in the treatment of
full-face wrinkles. | | |
| Power Source | Input: 100-240Vac
50/60Hz, 30.5
A/115Vac,
16A/230Vac
Output: 12Vdc,
240A | Unpublished | 90-264 VAC | Voltage: 100 to
240 volts, AC
Frequency:
50-60Hz
Intensity: 0.35 A | Different,
note 1 |
| Wavelengths | 630nm, 850nm,
940nm | 630nm, 660nm,
855nm, 940nm | Red: 640nm +/-
25nm
880nm +/- 50nm | Red: 630 nm
(OSRAM LS T67F)
NIR: 850 nm
(OSRAM SFH
4253) | Similar,
note 2 |
| Irradiance
source | LED | LED | LED | LED | Same |
| LED number | 1260 | 18240 | Unpublished | Total 288 LEDs
- 144 for 630 nm
and 144 for
850 nm - 244 for the face | Different
note3 |
| Elements of
Comparison | Subject device | Predicate device
(K153399) | Predicate device
(K232977) | Predicate device
(K223147) | Remark |
| | | | | and 44 for the
neck | |
| Intended
location Use | Full body | Full body | Full body | Full Face and neck | Same |
| Irradiance
(mW/cm²) | M1 (630nm): 4.2
mw/cm²
M2
(630nm+850nm):
18.7 mw/cm²
M3
(630+850+940nm):
60 mw/cm² | 60 mW/cm 2 | 640nm -
4.2mW/cm 2
880nm -
0.7mW/cm2 | 18.7 mW/cm²
(average of 6
measurement
location (including
one on the
neck) between 10
to 27
mW/cm²) | Same |
| LED distribution | Uniform distribution | Uniform
distribution | Uniform
distribution | Uniform distribution | Same |
| Treatment Time | M1: 20min
M2: 20min
M3: 30min | 5-30 min | 30min | According to skin
phototype,
daily - 1 fair skin: 5 min
35 (335 s) - 2 moderately dark
skin: 11
min 10 (670 s) - 3 dark skin: 13
min 55 (835 s)
during 6 to 8
weeks | Same |
6
7
8
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
9
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.