(59 days)
Not Found
No
The device description and performance studies focus on LED light emission and electrical/photobiological safety, with no mention of AI or ML algorithms for analysis, control, or other functions.
Yes
The device is intended for the treatment of full face wrinkles, which aligns with the definition of a therapeutic device as it aims to alleviate or treat a condition.
No
The device is described as a treatment device for full face wrinkles, emitting LED light to induce a photobiological effect for wrinkle reduction, and lacks any mentions of diagnostic capabilities, image processing, or AI for analysis.
No
The device description explicitly lists hardware components such as a mask with LEDs, a controller, a cradle, a pouch, and a USB cable. The performance studies also focus on testing the safety and performance of these hardware components.
Based on the provided information, the OPERA LEBODY device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of full face wrinkles" by emitting LED light onto the face. This is a therapeutic application, not a diagnostic one.
- Device Description: The device description focuses on the physical components and how it delivers light energy to the face. There is no mention of analyzing biological samples (like blood, urine, tissue, etc.) which is the core function of an IVD.
- Performance Studies: The performance studies described are related to the safety and performance of the device itself (wavelength, power, safety standards, etc.) and its effect on the skin (reduction of wrinkles). There are no studies related to the accuracy or reliability of a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The OPERA LEBODY device does not perform this function.
N/A
Intended Use / Indications for Use
OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.
Product codes
OHS
Device Description
The OPERA LEBODY is a device which allows emission of LED light in the red (630nm) and IR (830nm) spectrum onto the face, which induces photobiological effect to the face for reduction of wrinkle. OPERA LEBODY includes the mask that contains LEDs on the inner surface, the controller which turns on and off the device, a cradle that holds the face mask, a pouch that keeps the product, and USB cable that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
The user wears a mask and operates OPERA LEBODY using the controller. The device will automatically turn off after 10 minutes. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, OPERA LEBODY has protective eye guide which blocks light energy from LEDs.
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
Non-clinical tests: Measurement of wavelength, average output power, and total irradiance of treatment LEDs were performed. Other performance, such as safety of lamps and lamp systems, electromagnetic compatibility and electrical safety, were tested using following consensus standards:
- Basic safety and essential performance of the OPERA LEBODY is tested and evaluated according to the IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007+A1:2012.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2 Edition 4.0 2014-02.
- Photobiological safety of lamps and lamp systems is evaluated in accordance with -IEC 62471: 2006 (First Edition).
- Risk management was recorded by referring to ISO 14971: 2012. -
- Usability was documented by referring to IEC 60601-1-6: 2010, AMD1: 2013. -
The portion of the device that touches patient body is made of silicone and ABS plastics, which have been used for other medical devices without any biocompatibility risk.
Key Metrics
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
June 22, 2020
Image /page/0/Picture/1 description: The image contains 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.
GTG Wellness Co., Ltd. % Paweena U-Thainual CEO MDR Solutions Co., Ltd. 1435 Kanchanapisek Rd., Bang Khae Nuea Bangkok, Bang Khae 10160, Thailand
Re: K201107
Trade/Device Name: Opera Lebody (Gold), Opera Lebody (Zafiro) 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: April 23, 2020 Received: April 24, 2020
Dear Paweena U-Thainual:
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 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
1
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,
Colin Kejing Chen Acting 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
2
Indications for Use
510(k) Number (if known) K201107
Device Name OPERA LEBODY
Indications for Use (Describe)
OPERA LEBODY is an over the counter device that is intended for the 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)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K201107: 510(k) Summary
1. General Information
| Applicant/Submitter: | GTG Wellness Co., Ltd. |
|---|---|
| Address: | 7, Dongwon-ro, Bundang-gu, |
| Seongnam-si, Gyeonggi-do, | |
| Rep. of Korea (South Korea) | |
| Tel: +82 70-4733-8244 | |
| Contact Person: | Paweena U-Thainual, Ph.D. |
| MDR Solutions Co., Ltd. | |
| Address: | 1435 Kanchanapisek Rd., |
| Bang Khae Nuea, Bang Khae, | |
| Bangkok 10160, THAILAND | |
| Tel: +66 2-804-2101 | |
| Email: paweena@mdrsolutions.co.th | |
| Preparation Date: | April 3rd, 2020 |
2. Device Name and Code
| Device Trade Name: | OPERA LEBODY |
|---|---|
| Common Name: | OPERA LEBODY |
| Classification Name: | Light Based Over The Counter Wrinkle Reduction |
| Product Code: | OHS |
| Regulation Number: | 878.4810 |
| Classification: | Class II |
| Review Panel: | General & Plastic Surgery |
3. Predicate Device
OPERA LEBODY is substantially equivalent to the following legally marketed predicate devices
| Primary Predicate Device | Predicate Device | |
|---|---|---|
| 510(K) Number | K163329 | K133896 |
| Manufacturer | Pulsaderm LLC | Trophy Skin, Inc. |
| Device Name | Pulsaderm Wrinkle Mask 28 and | |
| Wrinkle Mask 72 | Rejuvalite MD | |
| Model Name | Pulsaderm Wrinkle Mask 28 | |
| Pulsaderm Wrinkle Mask 72 | Rejuvalite MD | |
| Clearance Date: | April 14, 2017 | November 13, 2014 |
Table 1 Predicate devices
4
K201107: 510(k) Summary
4. Device Description
The OPERA LEBODY is a device which allows emission of LED light in the red (630nm) and IR (830nm) spectrum onto the face, which induces photobiological effect to the face for reduction of wrinkle. OPERA LEBODY includes the mask that contains LEDs on the inner surface, the controller which turns on and off the device, a cradle that holds the face mask, a pouch that keeps the product, and USB cable that delivers electrical power to the controller for operation or for charging the battery contained in the controller.
The user wears a mask and operates OPERA LEBODY using the controller. The device will automatically turn off after 10 minutes. Emitted light from LEDs are not intended for ocular or ophthalmic treatment. To prevent irradiation of LED lights to eyes during the treatment, OPERA LEBODY has protective eye guide which blocks light energy from LEDs.
5. Indications / Intended Use
The OPERA LEBODY is an over the counter device that is intended for the use in the treatment of full face wrinkles.
6. Technical Characteristics in Comparison to Predicate Devices
| Primary Predicate Device | Predicate Device | Proposed Device | |
|---|---|---|---|
| 510(K) | |||
| Number | K163329 | K133896 | N/A |
| Manufacturer | Pulsaderm LLC | Trophy Skin, Inc. | GTG Wellness Co., Ltd. |
| Device Name | Pulsaderm Wrinkle Mask 28 | ||
| and Wrinkle Mask 72 | Rejuvalite MD | OPERA LEBODY | |
| Model Name | Pulsaderm Wrinkle Mask 28 | ||
| Pulsaderm Wrinkle Mask 72 | Rejuvalite MD | OLG-200, OLZ-200 | |
| Clearance | |||
| Date: | April 14, 2017 | November 13, 2014 | N/A |
| Product Code | OHS | OHS | OHS |
| Classification | |||
| / Regulation | Class II | Class II | Class II |
| Intended Use | |||
| / Indications | |||
| for Use: | The Pulsaderm Wrinkle | ||
| Masks 28 and 72 are | |||
| intended for the use in the | |||
| treatment of facial wrinkles | |||
| and for people with | |||
| Fitzpatrick Skin Types I, II | |||
| and III | The Rejuvalite MD is an | ||
| over-the-counter device | |||
| intended for the 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. | |||
| Type of Use | Over-The-Counter use | Over-The-Counter use | Over-The-Counter use |
| Light Source | LEDs | LEDs | LEDs |
| LED | |||
| emission | 2 types: |
- Red (620~630nm)
- IR (850nm) | 2 types:
- Red (600, 622,
660nm) - IR (860nm) | 2 types:
- Red (630nm)
- IR (830nm) |
| Number of
LEDs | Pulsaderm Wrinkle Mask
28: Total 28 LEDs | Total 120 LEDs | Total 78 LEDs |
The OPERA LEBODY is substantially equivalent to the following legally marketed predicate devices
5
OPERA LEBODY
K201107: 510(k) Summary
| | Pulsaderm Wrinkle Mask
72: Total 72 LEDs | | |
|----------------------------------|---------------------------------------------|-------------------------------------------------|--------------------------------------------------|
| Power
Density
(Irradiance) | 21.18 - 25.35 mW/cm² | 62 mW/cm² | 50 mW/cm² |
| Treatment
time | 15 minutes every day, 60
sessions | 3 minutes daily, 5 days per
week for 8 weeks | 10 minutes daily, 3 days per
week for 8 weeks |
| Treatment
area | Full Face | Full Face | Full Face |
7. Performance Data
Non-clinical tests: Measurement of wavelength, average output power, and total irradiance of treatment LEDs were performed. Other performance, such as safety of lamps and lamp systems, electromagnetic compatibility and electrical safety, were tested using following consensus standards:
- -Basic safety and essential performance of the OPERA LEBODY is tested and evaluated according to the IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007+A1:2012.
- Effect to the device by electromagnetic disturbances were tested and evaluated according to the FDA-recognized consensus standard IEC 60601-1-2 Edition 4.0 2014-02.
- Photobiological safety of lamps and lamp systems is evaluated in accordance with -IEC 62471: 2006 (First Edition).
- Risk management was recorded by referring to ISO 14971: 2012. -
- Usability was documented by referring to IEC 60601-1-6: 2010, AMD1: 2013. -
The portion of the device that touches patient body is made of silicone and ABS plastics, which have been used for other medical devices without any biocompatibility risk.
8. 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 the OPERA LEBODY, GTG Wellness Co., Ltd. believes that no significant differences in usage of its underlying technological principles between OPERA LEBODY and the predicate devices.
9. Conclusions
On the basis of the information provided in this Summary, GTG Wellness Co., Ltd. Believes that OPERA LEBODY is substantially equivalent to legally commercialized predicate devices for the purposes of this 510 (k) submission.