(139 days)
Not Found
No
The device description and the "Mentions AI, DNN, or ML" section explicitly state that AI/ML is not found. The device appears to be a simple LED light therapy device with basic timer functionality.
Yes.
The device is intended for the treatment of full face wrinkles, which is a therapeutic purpose.
No
The device description indicates its purpose is to emit light for the treatment of full face wrinkles, not to diagnose any condition.
No
The device description explicitly lists hardware components such as an LED device (a pad), adjustable strap, USB charging cord, and goggles.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Infrared Heat device described here is a light-emitting device that applies energy directly to the skin for the treatment of wrinkles. It does not analyze any biological samples.
- Intended Use: The intended use is "to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles." This is a therapeutic use, not a diagnostic one.
The description clearly indicates a device for direct treatment of a physical condition on the body, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.
Product codes (comma separated list FDA assigned to the subject device)
OHS
Device Description
The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time.
The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual.
The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
full face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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)
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.
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:
- AAMI/ANSI ES60601-1 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] 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.
- IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices
Biocompatibility
The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization) and ISO 10993-23 (Irritation).
Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA’S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
Usability Testing
Usability testing was conducted on the Infrared Heat (Models: E0221), which complies with IEC 62366-1 and IEC 60601-1-6.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
May 16, 2023
Light Tree Ventures Europe B.V. Alain Dijkstra Manager Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Hague, Netherlands
Re: K223893
Trade/Device Name: Infrared Heat (Model: E0221) 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 Dated: February 15, 2023 Received: February 15, 2023
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 (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.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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,
Jianting Wang -S
Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223893
Device Name Infrared Heat, model: E0221
Indications for Use (Describe)
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.
| 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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(k) Summary of K223893
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: Light Tree Ventures Europe B.V. Establishment Registration Number: 3017422691 Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: regulation@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra Company: Light Tree Ventures Europe B.V. Address: Laan van Ypenburg 108, 2497 GC, The Hague, The Netherlands Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
Manufacturer
Shenzhen Kaiyan Medical Equipment Co., Ltd Add: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China
Distributor
Company: Smart Recovery Technologies LLC Add: 132A Veterans Lane-451, Doylestown, PA 18901, USA
2. Subiect Device Information
Trade Name: Infrared Heat, model: E0221 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgerv Product Code: OHS Regulation Number: 21 CFR 890.5500, 21 CFR 878.4810 Regulation Class: II
3. Predicate Device Information
Predicate Device (K171323) Sponsor: BioPhotas, Inc. Trade Name: BioPhotas Celluma3 Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810
4
Regulation Class: II
Predicate Device (K201107)
Sponsor: GTG Wellness Co., Ltd. Trade Name: Opera Lebody Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Review Panel: General & Plastic Surgery Product Code: OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Device Description
The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time.
The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual.
The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.
5. Intended Use / Indications for Use
The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.
6. Comparison to predicate devices
Compare with the predicate device, 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
(K171323) | Predicate Device
(K201107) | Remark |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Company | Light Tree Ventures
Europe B.V. | BioPhotas, Inc. | GTG Wellness
Co., Ltd. | -- |
| Trade Name | Infrared Heat | Biophotas Celluma3 | Opera Lebody | -- |
| Model | E0221 | / | / | -- |
| Classification
Name | Laser surgical instrument
for use in general and
plastic surgery and in
dermatology | Laser surgical
instrument for use in
general and plastic
surgery and in
dermatology | Laser surgical
instrument for use
in general and
plastic surgery and
in dermatology | Same |
| 510(k) Number | K223893 | K171323 | K201107 | -- |
| Product Code | OHS | OHS | OHS | -- |
| Indications
for
Use | The Infrared Heat (Model:
E0221) is intended to emit
energy in the red and
infrared spectrum for use
in the treatment of full face
wrinkles. | The
BioPhotas
Celluma3 is intended to
emit energy in the
visible and infrared
region of the spectrum
for use in the treatment
of full face wrinkles. | OPERA LEBODY
is an over the
counter device
that is intended for
the use in the
treatment of full
face wrinkles. | Same |
| Type of Use | Over-The-Counter use | Over-The-Counter use | Over-The-Counter use | Same |
| Light Source | LEDs | LEDs | LEDs | Same |
| Power Supply | Main unit: 3.7V, 1800mAh
lithium battery, 6.66Wh
Adapter Input: 100-240Va.c., 50/60Hz
Adapter Output: 5Vd.c, 2A | 110-120V | No publicity | Different,
Note 1 |
| Wavelength | 630nm,830nm+/- 20nm | Red: 640nm+/-25nm
NIR: 880nm+/-50nm | 2 types:
- Red (630nm)
- IR (830nm) | Similar,
Note 3 |
| Panels Type | 1 Panel | 1 Panel | 1 Panel (Mask) | Same |
| Output Power | 630nm + 830nm: 30 mW/cm² | 6.5 mw/cm² | 50 mw/cm² | Different,
Note 2 |
| Standard dose
in Joules | 18J/cm² | 11.7J/cm² | 30J/cm² | Different,
Note 2 |
| LED distribution | Uniform distribution | Uniform distribution | Uniform distribution | Same |
| Treatment area | 208 | 158 | No publicity | Similar,
Note 3 |
| LED number | 630nm: 30
830nm: 30 | No public | Total 78 LEDs | Similar,
Note 3 |
| Treatment Time | 10 minutes per day, 2-5
times per week | 3 times a week for 30
min. 4 weeks | 10 minutes daily, 3
days per week for
8 weeks | Different,
Note 2 |
| Operation
interface | Device uses a timer and
software to control
treatment duration. | Device uses a timer
and software to control
treatment duration. | Device uses a
timer and software
to control
treatment duration. | Same |
| Software | Yes | Yes | Yes | Same |
| EMC | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| Safety | IEC 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 62471 | IEC 60601-1 | IEC 60601-1
IEC 62471 | Same |
| Biocompatibility | ISO 10993-1
ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | Same |
5
6
Comparison in Detail(s):
Note 1: Although the "Power Supply" is a little different from the predicate devices, but they all complied with the IEC 60601-1 and IEC 60601-1-2 safety standards' requirements. So, these slight differences will not raise any safety or effectiveness issues.
Note 2: Although the "Output Power", "Standard dose in Joules", and "Treatment Time" of the subject device and predicate devices are a little different, the "Output Power" and "Standard dose in Joules" of the subject device is not higher than Predicate Device (K201107), indicating the safety of the device, and not lower than Predicate Device (K171323), indicating the effectiveness of the device. Besides, the "Treatment Time" is similar to predicate device. So, the "Output Power", "Standard dose in Joules", and "Treatment Time" of the subject device and predicate devices does not affect the effectiveness and safety of the device.
Note 3: Although the "Wavelength", "Treatment area" and "LED number" are slightly different from the predicate device, their treatment doses are all safe and effective, ang they all complied with the requirement of IEC 60601-2-57 and IEC 62471 standards. So, these slight differences will not raise any safety or effectiveness issues.
7. Test Summary
7.1 Non-Clinical Tests Performed
-
- 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:
7
K223893
- AAMI/ANSI ES60601-1 2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) � [Incl. AMD2:2021] 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.
- � IEC 62133-2 Edition 1.0 2017-02 Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems.
- � IEC 60601-1-6 Edition 3.2 2020-07 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
- � IEC 62366-1 Edition 1.1 2020-06 Medical devices - Part 1: Application of usability engineering to medical devices
2) Biocompatibility
The subject device is biocompatible for its intended use. They are complied with biocompatibility standards ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Sensitization) and ISO 10993-23 (Irritation).
3) Software verification and validation testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA'S Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury.
4) Usability Testing
Usability testing was conducted on the Infrared Heat (Models: E0221), 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: May 13, 2023
9. Final Conclusion:
The subject device is as safe, as effective, and performs as well as or better than the legally marketed predicated devices K171323 and K201107.