(90 days)
Not Found
No
The summary describes a light therapy device with different wavelengths and a user interface. There is no mention of AI or ML in the intended use, device description, or performance studies. The software validation is for a "MODERATE level of concern software," which is typical for device control and user interface, not necessarily AI/ML.
Yes
The device is intended to treat specific medical conditions such as acne, periorbital wrinkles, and various types of pain (muscle, joint, arthritis). These uses fall under the definition of a therapeutic device as they are meant to alleviate or treat a disease or condition.
No
The device is described as a "Photo-Therapy Device" that uses LEDs to emit light for treating dermatological conditions and providing topical heating. Its intended uses are therapeutic (e.g., treating acne, wrinkles, pain relief) and do not involve identifying or determining the nature of a disease or condition.
No
The device description explicitly states it is a "portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs)" and lists hardware components like a stand, head, color touch screen, and power supply. While it has user interface software, it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described are all related to treating dermatological conditions (acne, wrinkles) and providing topical heating for pain relief and muscle relaxation. These are therapeutic applications, not diagnostic ones.
- Device Description: The device uses LEDs to emit light for therapeutic purposes. It does not involve analyzing biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVDs.
- Lack of IVD-related information: The document does not mention any aspects related to in vitro diagnostics, such as sample collection, analysis of biomarkers, or diagnostic interpretations.
In summary, the SMARTLUX MINI is a light therapy device intended for therapeutic use, not for diagnosing diseases or conditions using in vitro methods.
N/A
Intended Use / Indications for Use
Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible 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 relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
Product codes (comma separated list FDA assigned to the subject device)
GEX, ILY
Device Description
The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- · Red (630-640nm)
- · Blue (415-425nm)
- · Yellow (585-595nm)
- Infra-red (820-830nm)
This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
The SMARTLUX MINI conforms with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The SMARTLUX MINI conforms with the electrical safety and electromagnetic compatibility requirements established by the standards.
- Software Validation
The SMARTLUX MINI contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated.
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 contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
July 12, 2022
MEDMIX Co., Ltd. % Jonghyun Kim Chief Consultant GMS Consulting 4th Floor, Digital Cube, 34, Sangamsan-ro Seoul, Mapo-gu 03909 Korea, South
Re: K221083
Trade/Device Name: Smartlux Mini 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: GEX, ILY Dated: April 11, 2022 Received: April 13, 2022
Dear Jonghyun Kim:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 mediation-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 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) K221083
Device Name SMARTLUX MINI
Indications for Use (Describe)
Blue (415-425mm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830mm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible 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 relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X 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
[As Required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
April 11, 2022
2. Submitter's Information [21 CFR 807.92(a)(1)]
- Name of Manufacturer: MEDMIX Co., Ltd
- Address: B-707 Smartvalley, 30, Songdomirae-ro, Yeonsu-gu, Incheon, Republic of Korea ● Contact Name: Yunseok Yu ● Telephone No.: +82 10-9487-8160 ● Email Address: ysyu@medmix.co.kr ● Registration No.: K221083
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| 510(k) Number | K221083 |
|---|---|
| Trade/Device/Model Name | SMARTLUX MINI |
| Product Name | Phototherapy Unit |
| Device Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 21 CFR 878.4810 / 21 CFR 890.5500 |
| Classification Product Code | GEX (Primary), ILY (Secondary) |
| Device Class | 2 |
| 510(k) Review Panel | General & Plastic Surgery / Physical Medicine |
4
4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)]
The identified predicate device within this submission is shown as follow;
Predicate Device
| 510(k) Number | K192755 |
|---|---|
| Trade/Device/Model Name | Soli-Lite LG4 Galileo |
| Product Name | Phototherapy Unit |
| Device Classification Name | Powered Laser Surgical Instrument |
| Regulation Number | 21 CFR 878.4810 / 21 CFR 890.5500 |
| Classification Product Code | GEX (Primary), ILY (Secondary) |
| Device Class | 2 |
| 510(k) Review Panel | General & Plastic Surgery / Physical Medicine |
5
5. Description of the Device [21 CFR 807.92(a)(4)]
The Photo-Therapy Device SMARTLUX MINI is a portable device which uses specific wavelengths of light, produced by light emitting diodes (LEDs).
The device produces light in the following regions of the light spectrum:
- · Red (630-640nm)
- · Blue (415-425nm)
- · Yellow (585-595nm)
- Infra-red (820-830nm)
This device's main components are the stand, the head, color touch screen, and the power supply. User interface software allows the operator to access and control all device functions.
6. Indications for use [21 CFR 807.92(a)(5)]
Blue (415-425nm), is generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
Red (630-640nm) and Infrared (820-830nm) Combination is intended to emit energy in the red and infrared region of the spectrum for use in dermatology for the treatment of periorbital wrinkles.
Combination of Infrared (820-830nm) and Yellow (585-595nm) is intended to emit energy in the IR and visible spectrum to provide topical heatinq 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 relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.
6
7. Technological Characteristics (Equivalence to Predicate Device) [21 CFR 807.92(a)(6)]
Provided below is a table summarizing and comparing the technological characteristics of the SMARTLUX MINI and the predicate device:
| Subject Device | Predicate Device | |
|---|---|---|
| Product Name | Phototherapy Unit | Phototherapy Unit |
| Model Name | SMARTLUX MINI | Soli-Lite LG4 Galileo |
| Manufacturer | MEDMIX Co., Ltd. | Silhouet-Tone Corporation |
| Indications for Use | Blue (415-425nm), is generally indicated to treat dermatological | |
| conditions and specifically indicated to | ||
| treat moderate inflammatory acne | ||
| vulgaris. | ||
| Red (630-640nm) and Infrared (820- | ||
| 830nm) Combination is intended to | ||
| emit energy in the red and infrared | ||
| region of the spectrum for use in | ||
| dermatology for the treatment of | ||
| periorbital wrinkles. | ||
| Combination of Infrared (820-830nm) | ||
| and Yellow (585-595nm) is intended | ||
| to emit energy in the IR and visible | ||
| 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 relaxation of | ||
| muscle tissue; and to temporarily | ||
| increase local blood circulation where | ||
| applied. | Blue (410-415nm), is generally indicated to treat dermatological | |
| conditions and specifically indicated to | ||
| treat moderate inflammatory acne | ||
| vulgaris. | ||
| Red (620-633nm) and Infrared (820- | ||
| 830nm) Combination is intended to | ||
| emit energy in the red and infra-red | ||
| region of the spectrum for use in | ||
| dermatology for the treatment of | ||
| periorbital wrinkles. | ||
| Combination of Infrared (820- 830nm) | ||
| and Yellow (585-595nm) is intended | ||
| to emit energy in the IR and visible | ||
| 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 relaxation of | ||
| muscle tissue; and to temporarily | ||
| increase local blood circulation where | ||
| applied. | ||
| Submission | ||
| Number | K221083 | K192755 |
| Product Code | GEX (Primary), ILY (Secondary) | GEX (Primary), ILY (Secondary) |
| Device Class | 2 | 2 |
| Configuration | Portable | Portable |
| Components | Stand, Head, Color touch screen, | |
| Power supplier | Main frame, irradiator, lifting stand | |
| Wavelength | RED 630-640nm | |
| BLUE 415-425nm | ||
| IR: 820-830nm | ||
| YELLOW: 585-595nm | Red 620-633nm | |
| Blue 410-415nm | ||
| IR 820-830nm / Yellow 585- 595nm | ||
| Effective | ||
| irradiance | Adjustable 5 levels | |
| Red : 26-50 mW/cm2 | ||
| Blue : 9~41 mW/cm2 | ||
| Yellow: 12-20 mW/cm2 | ||
| IR: 11~28 mW/cm2 | Adjustable 4 levels | |
| Red: 19-47mW/cm2 | ||
| Blue: 25-40mW/cm2 | ||
| IR/Yellow: 29-61mW/cm2 | ||
| Operation | ||
| interface | Continuous operation | Continuous operation |
| Subject Device | Predicate Device | |
| Operation mode | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-57 | ||
| IEC 62471 | IEC 60601-1 | |
| IEC 60601-1-2 | ||
| IEC 60601-2-57 | ||
| IEC 62471 | ||
| Microprocessor | ||
| control | Yes | Yes |
| Continuous/Pulsed | ||
| Output | Continuous and Pulsed (up to 500 pulses | |
| per second) | Continuous |
7
The proposed device, SMARTLUX MINI has been tested about electrical safety, EMC, and performance, and the software has been validated. Differences and Risks associated with that:
- · The components of the subject device have similar composition as the components of the predicate device This difference does not influence the effectiveness and safety of product.
- • The wavelengths and intensities emitted from subject device are similar to the wavelengths and intensities emitted by the predicate device. The predicate device emits light continuously during its treatment cycles. The SMARTLUX MINI also emits light continuously but it also has the option of emitting 50% duty cycle pulses at up to 500 times per second. This difference does not influence the effectiveness and safety of product.
8
8. Non-Clinical Test summary
The SMARTLUX MINI conforms with voluntary standards for electrical safety, electromagnetic compatibility. The following data were provided in support of the substantial equivalence determination:
- Electrical Safety, Electromagnetic Compatibility and Performance:
The SMARTLUX MINI conforms with the electrical safety and electromagnetic compatibility requirements established by the standards.
| Standards
No. | Standards
Organization | Standard Title | Version | Publication
Year |
|------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|---------------------|
| ES60601-1 | AAMI ANSI | Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and Essential
Performance (IEC 60601-1:2005, MOD) | ES60601-1:
2005(R)201
2 and
A1:2012 | 2014 |
| 60601-1-2 | IEC | Medical Electrical Equipment - Part 1-2:
General Requirements for Safety - Collateral
Standard: Electromagnetic Compatibility -
Requirements and Tests | 60601-1-2
Edition 4.0
2014-02 | 2016 |
| 60601-2-57 | IEC | 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 | 60601-2-57
Edition 1.0
2011-01 | 2012 |
| 62471 | IEC | Photobiological safety of lamps and lamp
systems | IEC 62471
First edition
2006-07 | 2012 |
2) Software Validation
The SMARTLUX MINI contains MODERATE level of concern software. The software was designed and developed according to a software development process and was verified and validated. Software information is provided in accordance with FDA quidance:
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005).
9
9. Conclusion [21 CFR 807.92(b)(3)]
The SmartLux Mini light-emitting device that is the subject of this premarket notification uses similar technology and emits wavelengths and intensities of light that are similar to the predicate K192755. Testing of key performance characteristics demonstrates that the subject device can be used safely and effectively for the proposed indications for use. The Smartlux Mini light emitting device is considered to be substantially equivalent to the predicate device K192755.