(86 days)
Not Found
No
The device description and performance studies focus on light therapy and electrical/mechanical safety standards, with no mention of AI or ML capabilities.
Yes
The device is indicated for the treatment of full face wrinkles and mild to moderate acne vulgaris, which are stated therapeutic claims.
No
The device is indicated for treatment of wrinkles and acne, not for diagnosis.
No
The device description clearly outlines a physical hardware device (a mask) that emits light for therapeutic purposes. It mentions a built-in battery, charging cradle, and physical components like eye shields. While it mentions software in the performance studies section, this software is clearly part of the control system for the hardware, not a standalone software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of full face wrinkles and mild to moderate acne. IVD devices are used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This device directly applies light therapy to the skin for therapeutic purposes.
- Device Description: The description details a light-emitting mask that is worn on the face and irradiates the skin with specific wavelengths of light. This aligns with a therapeutic device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of collecting or analyzing biological samples, performing tests on those samples, or providing diagnostic information based on such tests.
The device is clearly described as a therapeutic device utilizing light energy for treatment.
N/A
Intended Use / Indications for Use
LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face.
Product codes
OHS, OLP
Device Description
The LED MASK EXCLUSIVE MD is an over the counter device that is intended for the treatment of full face wrinkles with red light and infrared light and mild to moderate acne with blue light. This product irradiates the skin with blue light in the wavelength range of 400 ~ 440mm, red light in the wavelength range of 630 ~ 690mm, and infrared light in the wavelength range of 820 ~ 880mm.
This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
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)
Performance test:
- Basic safety and essential performance of the LED MASK EXCLUSIVE MD is tested ● and evaluated according to the FDA-recognized consensus standard, ES 60601-1.
- Photobiological safety of lamps and lamp systems is evaluated in accordance with IEC 62471:2006.
- The basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use is evaluated IEC 60601-2-57:2011.
- The basic safety and essential performance of medical electrical equipment and medical electrical systems used in the home healthcare environment is evaluated in accordance with IEC 60601-1-11:2015.
- Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6:2010.
Biocompatibility
- "Systemic-Acute Systemic Toxicity" and "systemic toxicity Annex G Information ● on material-mediated pyrogens" are evaluated in accordance with ISO 10993-11:2017.
- "In vitro cytotoxicity" is evaluated in accordance with ISO 10993-5:2009. ●
- "Irritation and skin sensitization" is evaluated in accordance with ISO 10993-10:2010,
Software
- Software life cycle process is referred to IEC 62304:2006.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices : FDA Guidance is referred.
EMC
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014.
Sterility and Shelf Life
- LED MASK EXCLUSIVE MD is not supplied sterile. ●
- The shelf life is recorded by referring to ISO 14971.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). On the left side of the logo is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2023
Stg24 Co.,ltd. % Do Kim CEO BT Solutions, Inc. Unit 904, Eonju-ro 86-gil 5, Gangnam-gu Seoul. 06210 Korea, South
Re: K232795
Trade/Device Name: Led Mask Platinum Exclusive MD 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, OLP Dated: September 12, 2023 Received: September 12, 2023
Dear Do 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 (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/cdrb/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.
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 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).
2
Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatory-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.
Tanisha L. Tanisha L. Hithe -s 2023.12.07 Hithe -S 21:44:10 -05'00'
Tanisha Hithe, MS, MHS 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name LED Mask EXCLUSIVE MD
Indications for Use (Describe)
LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face writh red light and infrared light and treat mild to moderate acne vulgaris of the face.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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4
| LED MASK EXCLUSIVE MD |
|---|
| ----------------------- |
510(k) Summary
K232795 5. 510(k) Summary
5.1 General Information
| Applicant/Submitter: | STG24 CO.,LTD. |
|---|---|
| Address: | 237, Namdongseo-Ro. Namdong-Gu, |
| Incheon, Republic of Korea, 21634 | |
| Contact Person: | Do Hyun Kim, BT Solutions, Inc. |
| Address: | Unit 904, Eonju-ro 86gil 5, |
| Gangnam-gu, Seoul 06210, Korea. | |
| Tel: +82-2-538-9140 | |
| Email: ceo@btsolutions.co.kr | |
| Preparation Date: | December 4, 2023 |
5.2 Device Name and Code
| Device Trade Name: | LED MASK EXCLUSIVE MD |
|---|---|
| Model Name: | ME-M20M4 |
| Common Name: | Light Based Over The Counter Wrinkle |
Classification Name:
Product Code: Regulation Number: Classification: Review Panel:
Reduction & Over-The-Counter Powered Light Based Laser For Acne
Light Based Over The Counter Wrinkle Reduction & Over-The-Counter Powered Light Based Laser For Acne
OHS & OLP 21 CFR 878.4810
Class II
General & Plastic Surgery
5.3 Technical Characteristics in Comparison to Predicate Devices
| 510(k) Number | K190443 |
|---|---|
| Manufacturer | Galactic Beauty, LLC |
| Device Name | MMSphere |
| Product code | OLP, OHS |
| Regulation number | 21 CFR 878.4810 |
| Classification | Class II |
Table 5.1 Primary Predicate Devices
5
LED MASK EXCLUSIVE MD
510(k) Summary
| 510(k) Number | K222377 |
|---|---|
| Manufacturer | LED Mask Platinum MD |
| Device Name | STG24 Co., LTD |
| Product code | OHS |
| Regulation number | 21 CFR 878.4810 |
| Classification | Class II |
Table 5.2 Secondary Predicate Device
The LED MASK EXCLUSIVE MD, is substantially equivalent to the following legally marketed predicate devices. K190443 is for 415nm wavelength, K22377 is for 655nm and 845nm wavelength.
| Proposed Device | K190443 | K222377 | |
|---|---|---|---|
| Company | LED Mask EXCLUSIVE | ||
| MD | Galactic Beauty, LLC | LED Mask Platinum | |
| MD | |||
| Product name | STG24 CO., LTD. | MMSphere | STG24 Co., LTD |
| Product code | OLP | OLP, OHS | OHS |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Classification | Class II | Class II | Class II |
| Intended Use | LED MASK | ||
| EXCLUSIVE MD is an | |||
| over the counter device | |||
| that is indicated for the | |||
| treatment of full face | |||
| wrinkles with red light | |||
| and infrared light and | |||
| treat mild to moderate | |||
| acne vulgaris of the face. | MMSphereTM Light | ||
| Therapy Device emits | |||
| energy in the red, blue | |||
| and amber regions of the | |||
| spectrum, specifically | |||
| indicated to treat | |||
| wrinkles and/or mild to | |||
| moderate acne. The | |||
| MMSphereTM is | |||
| designed to be used for | |||
| 20 minute treatments | |||
| three to seven times per | |||
| week. | LED MASK | ||
| PLATINUM MD is an | |||
| over the counter device | |||
| that is indicated for the | |||
| treatment of full face | |||
| wrinkles. | |||
| Type of use | OTC | OTC | OTC |
| Technological | |||
| characteristics | |||
| Shape of device | Mask type | Panel type | Mask type |
| Wavelength | 415 nm | ||
| 655 nm | |||
| 845 nm | 465 nm | ||
| 625 nm | |||
| 605 nm | 630-690 nm | ||
| 820-880 nm | |||
| Power | |||
| (mW/cm2) | - Red: 1 + NIR: 1 |
- Blue: 1 | - RED:2.45
- BLUE:1.33 | 2 |
| Energy dose
(J/cm2) | 1.2 | - RED:2.94 - BLUE: 1.596 | 0.96 |
6
LED MASK EXCLUSIVE MD
510(k) Summary
| Treatment time
| (min) | 20min/day, 120day | 20min/day, 120day | 8min/day |
|---|---|---|---|
| Number of LEDs | 1026 ea | 383 ea | 684ea |
Table 5.3 Comparison between the proposed device and the predicate devices
5.4 Device Description
The LED MASK EXCLUSIVE MD is an over the counter device that is intended for the treatment of full face wrinkles with red light and infrared light and mild to moderate acne with blue light. This product irradiates the skin with blue light in the wavelength range of 400 ~ 440mm, red light in the wavelength range of 630 ~ 690mm, and infrared light in the wavelength range of 820 ~ 880mm.
This product is designed as a portable personal medical device with a built-in battery, not a wired power supply. It is a mask-type product that is worn on the face. The operating mode of the product can be easily changed by hand. After connecting the charging adapter to the cradle, attach the main unit to the cradle to wirelessly charge the main unit with only the cradle. In addition, eye shield (for eye protection, opening/closing covers, vacuum cleaner towels, power cables, etc. are provided for convenient service use.
5.5 Indications / Intended Use
LED MASK EXCLUSIVE MD is an over the counter device that is indicated for the treatment of full face wrinkles with red light and infrared light and treat mild to moderate acne vulgaris of the face.
5.6 Non-clinical test
Performance test:
- Basic safety and essential performance of the LED MASK EXCLUSIVE MD is tested ● and evaluated according to the FDA-recognized consensus standard, ES 60601-1.
- Photobiological safety of lamps and lamp systems is evaluated in accordance with IEC 62471:2006.
- The basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use is evaluated IEC 60601-2-57:2011.
- The basic safety and essential performance of medical electrical equipment and medical electrical systems used in the home healthcare environment is evaluated in accordance with IEC 60601-1-11:2015.
- Risk management was recorded by referring to ISO 14971.
- Usability was documented by referring to IEC 60601-1-6:2010.
Biocompatibility
- "Systemic-Acute Systemic Toxicity" and "systemic toxicity Annex G Information ● on material-mediated pyrogens" are evaluated in accordance with ISO 10993-11:2017.
7
LED MASK EXCLUSIVE MD
510(k) Summary
- "In vitro cytotoxicity" is evaluated in accordance with ISO 10993-5:2009. ●
- "Irritation and skin sensitization" is evaluated in accordance with ISO 10993-10:2010,
Software
- Software life cycle process is referred to IEC 62304:2006.
- Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices : FDA Guidance is referred.
EMC
-
Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2:2014.
Sterility and Shelf Life -
LED MASK EXCLUSIVE MD is not supplied sterile. ●
-
The shelf life is recorded by referring to ISO 14971.
5.7 Substantial Equivalence
The proposed device uses similar or identical technology as the predicate devices and has same intended uses. Based upon the predicted overall performance characteristics for MMSphere, Galactic Beauty, LLC and Led Mask Platinum Md, STG24 CO.,LTD.. believes that no significant differences in usage of its underlying technological principles between LED MASK EXCLUSIVE MD and the predicate devices.
5.8 Conclusions
On the basis of the information provided in this Summary, STG24 CO.,LTD. believes that LED MASK EXCLUSIVE MD is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.