(449 days)
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne. This device is indicated for adults only.
The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution. The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.
The provided text describes a 510(k) premarket notification for the "Infrared Red Blue LED Light Heat Beauty Machine." This document focuses on demonstrating substantial equivalence to predicate devices based on non-clinical testing and comparison of specifications, rather than detailing a specific clinical study with acceptance criteria and device performance evaluation in the typical sense of a diagnostic or AI-powered medical device.
Therefore, the requested information regarding acceptance criteria, performance from a clinical study, sample sizes for test and training sets, expert qualifications, ground truth establishment, and MRMC studies is largely not applicable or not provided in this document, as the submission relies on non-clinical tests and comparisons to existing devices for substantial equivalence.
Here's a breakdown of the information that can be extracted and an explanation of why other requested details are missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists compliance with specific international standards as the "acceptance criteria" for non-clinical aspects. The reported "device performance" in this context refers to its conformity with these standards and a comparison of its specifications to predicate devices. There are no specific performance metrics (e.g., sensitivity, specificity, accuracy) like one would find for a diagnostic device.
| Acceptance Criteria (Non-Clinical Standards Compliance) | Reported Device Performance (Conformity) |
|---|---|
| IEC 60601-1 (Basic Safety & Essential Performance) | Comply with IEC 60601-1, IEC 60601-1-11 |
| IEC 60601-1-2 (EMC) | Comply with IEC 60601-1-2 |
| IEC 60601-1-11 (Home Healthcare Environment) | Comply with IEC 60601-1, IEC 60601-1-11 |
| IEC 60601-2-57 (Non-laser light source equipment) | Not explicitly stated as "comply," but listed as a standard the device met. It's implied compliance. |
| IEC 62471 (Photobiological Safety) | Comply with IEC 62471 |
| ISO 14971 (Risk Management) | Not explicitly stated as "comply," but listed as a standard the device met. It's implied compliance. |
| ISO 10993-5 (In Vitro Cytotoxicity) | Comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 |
| ISO 10993-10 (Irritation & Skin Sensitization) | Comply with ISO 10993-1, ISO 10993-5 and ISO 10993-10 |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided for clinical data. The document explicitly states: "Clinical data was not including in this submission."
- For the non-clinical tests (electrical safety, biocompatibility, photobiological safety, EMC), sample sizes and data provenance are not detailed, as these are typically conducted in a laboratory setting per standard requirements.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable / Not Provided. There was no clinical test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. No clinical test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is not an AI-powered device, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm-only device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided for clinical data. For the non-clinical tests, ground truth is established by adherence to the specified international standards and measurement methodologies defined within those standards.
8. The sample size for the training set:
- Not Applicable. This device is not an AI/machine learning product and therefore does not have a "training set" in that context.
9. How the ground truth for the training set was established:
- Not Applicable. No training set.
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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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
May 20, 2022
Marci Beauty Inc % Helen Nan General Manager Wenzhou Cytech Information Service Co., Ltd. Room302, Building 3, Hangqian Mansion, Hangian Street, Lucheng District Wenzhou. Zhejiang 325000 China
Re: K210545
Trade/Device Name: Infrared Red Blue LED Light Heat Beauty Machine 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: OLP, OHS Dated: October 13, 2020 Received: February 25, 2021
Dear Helen Nan:
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.
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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 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,
Purva Pandya 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
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Indications for Use
510(k) Number (if known) K210545
Device Name Infrared Red Blue LED Light Heat Beauty Machine
Indications for Use (Describe)
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the blue light is intended for the treatment of the mild to moderate inflammatory acne.
This device is indicated for adults only.
| 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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K210545 510(k) Summary
1.0 Submitter Information
| Company: | Marci Beauty Inc |
|---|---|
| Address: | 4290 Cameron st, Unit 7,Paradise NV 89103, U.S. |
| Phone: | 086-180-26309981 |
| Contact Person: | Shaul Rappaport |
| E-mail: | service@spacetouch.com |
| 2.0 Device Information |
| Trade/Device Name: | Infrared Red Blue LED Light Heat Beauty Machine |
|---|---|
| Model: | Vega; Jupiter; Neptune |
| Regulation Description: | Laser surgical instrument for use in general and plasticsurgery and in dermatology |
| Device: | Light Based Over The Counter Wrinkle Reduction;Over-The-Counter Powered Light Based Laser For Acne |
| Common Name: | Acne and Wrinkle Light Therapy System |
| Product Code: | OLP, OHS |
| Review Panel: | General & Plastic Surgery |
| Submission Type: | 510(k) |
| Regulation Number: | 21 CFR 878.4810 |
| Device Class: | Class II |
3.0 Predicate Device Information
| Device Name | 510K Number | Submitter |
|---|---|---|
| Aduro Light Therapy Handheld | K203271 | Shenzhen Kaiyan Medical CO LTD |
| LED FACIAL LIGHTTHERAPY MASK (Model: HK207) | K200983 | Ningbo Hesi Electric Co., Ltd |
| Elevare Plus | K172909 | Omm Imports d/b/a Zero Gravity |
| Sapphire, Elevare Sapphire | K172555 | Omm Imports, Inc. d/b/a Zero Gravity |
4.0 Device Description
The proposed device Infrared Red Blue LED Light Heat Beauty Machine, is a over-the-counter device hat uses low power light spectrum at red blue and infrared LED, at wavelength of 625±5nm, 465mm, 850±5nm emitting optical power in a uniform distribution.
The device is composed of a handpiece for delivery of light energy, base unit for charging and storage when not in use, and A.C.charging adapter. It is a hand-held light emitting diode (LED) device for treatment of wrinkles on face and mild to moderate inflammatory acne designed for home use.
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5.0 Indications for Use
The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the blue light is intended for the treatment of the mild to moderate inflammatory acne.
This device is indicated for adults only.
6.0 Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device conforms to the following standards:
| Standard | Title |
|---|---|
| IEC 60601-1 | Medical Electrical Equipment - Part 1: General Requirements for |
| Basic Safety and Essential Performance | |
| Medical electrical equipment - Part 1-2: General requirements for | |
| IEC 60601-1-2 | basic safety and essential performance - Collateral Standard: |
| Electromagnetic disturbances - Requirements and tests | |
| IEC 60601-1-11 | Medical Electrical Equipment - Part 1-11: 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 | 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 62471 | Photobiological safety of lamps and lamp systems |
| ISO 14971 | Application of risk management to medical devices |
| ISO 10993-5 | Biological evaluation of medical devices - Part 5: Tests for In |
| Vitro cytotoxicity | |
| ISO 10993-10 | Biological evaluation of medical devices - Part 10: Tests for |
| irritation and skin sensitization |
7.0 Clinical Test Conclusion
Clinical data was not including in this submission.
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8.0 Substantial Equivalence
The Infrared Red Blue LED Light Heat Beauty Machine is substant with the legally marketed device. The Infrared Red Blue LED Light Heat Beauty Machine have been tested for biocompatibility, electrical safety, and other physical performance as documented above and meet or exceed the applicable requirements of the recated standards and therefore the proposed product is as safe and as effective for it's intended use.
The table below shows similarities and differences between the predicate device and the subject device.
| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
|---|---|---|---|---|---|
| Name | Infrared Red Blue LED Light Heat Beauty Machine | Aduro light therapy Handheld | The LED FACIAL LIGHT THERAPY MASK | Elevare Plus | SAPPHIRE |
| 510k number | K210545 | K203271 | K200983 | K172909 | K172555 |
| Classification | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Product code | OHS,OLP | OHS,OLP | OHS,OLP | OHS | OLP |
| Use | OTC | OTC | OTC | OTC | OTC |
| Model | Vega; Jupiter; Neptune | HD-03A | HK207 | - | - |
| Indication for Use | The Infrared Red Blue LED Light Heat Beauty Machine is an hand-held over-the-counter phototherapy device, the red and infrared light is intended for the use in treating wrinkles on the face and the | The Aduro light therapy Handheld (Model: HD-03A), the red light is intended for the treatment of periorbital wrinkles, and the blue light is intended for the treatment of the mild to moderate | The LED FACIAL LIGHT THERAPY MASK is intended to: - The device emitting energy in the blue is intended to reduce the mild to moderate inflammatory acne vulgaris. - The device emitting | The Elevare Plus is an Over-the-Counter (OTC) device intended for the use in treating wrinkles on the face. | The SAPPHIRE is an over - the -counter hand held, battery operated, light therapy device that uses light emitting diodes (LEDs) that emit a specific wavelength of 415nm (Blue Light) that is intended for use |
| inflammatory acne. | in the treatment of | ||||
| blue light is intendedfor the treatment of themild to moderateinflammatory acne.This device isindicated for adultsonly. | energy in the red andinfrared spectrum isintended for thetreatment of full-facewrinkles. | mild to moderateinflammatory acne. | |||
| AnatomicalSites | Entire Face | Entire Face | Entire Face and Body | Entire Face | Entire Face |
| Design | Hand-held Type | Hand-held Type | Face-wear Type | Hand-held device | Hand-held device |
| TargetPopulation | Adult with wrinkles onface;Adult with mild tomoderateinflammatory acne | Individuals withperiorbital wrinkles onface, Individualswith mild to moderateinflammatory acne | Adult with wrinkles onface;Adult with mild tomoderateinflammatory acne | Individuals withwrinkles on face | Adult with mild tomoderate inflammatoryacne |
| The distancebetween theLEDs totreatmentsurface | 2 - 3 cm | Does not directlycontact the patient;approximately 2-6inches | 0.5 - 3 cm | Direct contact | Direct contact |
| Treatmentregimen | 3 times a week for 30min. 4 weeks | 3-5 minutes on eachtreatment area.For best results 3-5times per week with 2day rest. | 3 times a week for 30min. 4 weeks | 3 minutes daily, 5 daysper week for 8 weeks | 4 minutes per area,twice per week for 4weeks (total of 8treatments) |
| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
| Wavelengths | Blue: 465nmRed: 620-630nmIR: 845-855nm | Blue: 415 $\pm$ 10nmRed: 630 $\pm$ 10nmIR: 850nm | Blue: 465nmRed: 640nmIR: 880nm | Red: 610nm, 630nm,660nmIR: 850 $\pm$ 5nm | Blue: 415 $\pm$ 5nm |
| Main UnitWeight | 265g | 135g $\pm$ 2g | Not publicly available | 150g | Not publicly available |
| HousingMaterials ofmain unit | ABS Plastic andAluminum Head | ABS Plastic | biocompatible material | GLASS PROBE(HEAD) | GLASS PROBE(HEAD) |
| Power Supply | 900mAh,Rechargeable Li-Ionbatteries | 2600mAh,3.7V Li battery | Input: 100 - 240Vac,2.0 A, 50/60Hz | 2 Li-Ionrechargeablebatteries | rechargeable Li-Ionbatteries |
| Electricalpower | 100~240V AC50/60HZ 0.5A | Not publicly available | Input: 100 - 240Vac,2.0 A, 50/60Hz | 100~240V AC50/60HZ 0.35A | 100~240V AC50/60HZ 0.7A |
| Energy Source | 24 LEDs | Not publicly available | Not publicly available | 25 LEDs | Not publicly available |
| Intensity(mW/cm²) | Blue Light Mode: 5.4Red Light Mode: 7.2 | Blue: 20-65Red: 40-80 | 6.5 | 65 $\pm$ 5 | 50 |
| Software | Yes | Yes | Yes | Yes | Yes |
| AutomaticShut Off | Yes8 Minutes | Yes3 Minutes | Not publicly available | Yes | Yes |
| Temperaturestabilizer | 40 $\pm$ 2°C | Not publicly available | Not publicly available | 41 $\pm$ 2°C | 40-42 °C |
Table 1 -General Comparison
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Table 2 - Performance Comparison
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| Device | Subject Device | Predicate Device #1 | Predicate Device #2 | Predicate Device #3 | Predicate Device #4 |
|---|---|---|---|---|---|
| Electric Safety | Comply with IEC60601-1,IEC 60601-1-11 | Not publicly available | Comply with IEC60601-1,IEC 60601-1-11 | Comply with IEC60601-1,IEC 60601-1-11 | Comply with IEC60601-1,IEC 60601-1-11 |
| PhotobiologicalSafety | Comply with IEC62471 | Not publicly available | Not publicly available | Comply with IEC62471 | Comply with IEC62471 |
| EMC | Comply with IEC60601-1-2 | Not publicly available | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 |
| Bioconpatibility | Comply with ISO10993-1,ISO 10993-5 and ISO10993-10 | Comply with ISO10993-1,ISO 10993-5 and ISO10993-10 | Comply with ISO10993-1,ISO 10993-5 and ISO10993-10 | Comply with ISO10993-1,ISO 10993-5 and ISO10993-10 | Comply with ISO10993-1,ISO 10993-5 and ISO10993-10 |
Table 3-Safety Comparison
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9.0 Conclusion
Taking into consideration the table for substantial equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the proposed device raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate device.
§ 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.