(89 days)
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15, HD-15A) is a hand-held, battery-powered device used to stimulate the face and neck superficially through application of transcutaneous electrical currents and treat wrinkles by emitting 630 nanometers of red light. The device is powered by a Lithium-lon rechargeable battery, and it has a charging cable, carrying case and instruction manual.
There are two models of the device, with only differences in operating modes. Model HD-15 only has a red-light wrinkle treatment effect, while Model HD-15A has two functional modes: one is red light wrinkle treatment, and the other is micro current stimulation of the face and neck.
Both of them have one button to turn on/off the device. For model HD-15A, this button also can switch the mode.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes. After every three minutes of treatment, the device will vibrate the time. If you need to continue treatment, simply turn on the device again.
This document describes the Radiant Renewal Skincare Wand (Models: HD-15, HD-15A), a device intended for treating facial wrinkles and for facial and neck stimulation.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA 510(k) summary provided heavily relies on compliance with established international safety and performance standards for its acceptance criteria, rather than specific numerical performance metrics for wrinkle reduction or stimulation effects. The "reported device performance" is primarily stated as compliance with these standards and noted similarities/differences to predicate devices without raising new safety or effectiveness concerns.
| Acceptance Criteria Category | Specific Criteria (Standard Compliance) | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1 2020-08 Ed. 3.2 (General requirements for basic safety and essential performance) | Compliant |
| IEC 60601-1-11 Ed. 2.1 2020-07 (Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment) | Compliant | |
| IEC 60601-2-10 Ed. 2.1 2016-04 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators) | Compliant (Differences in Max Output Voltage, Max Current Density, Frequency range, Pulse duration, Max Phase Charge, Max Current Density, Max Power Density are noted as complying with this standard and not raising safety concerns.) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2 Ed. 4.1 2020-09 (EMC - Requirements and tests) | Compliant |
| Photobiological Safety | IEC 62471 First Ed. 2006-07 (Photobiological safety of lamps and lamp systems) | Compliant |
| IEC 60601-2-57 Ed. 1.0 2011-01 (Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use) | Compliant (Irradiance values, though slightly different from predicates, are noted as similar to other market devices for the same purpose and compliant with this standard.) | |
| Battery Safety | IEC 62133-2 Ed. 1.0 2017-02 (Secondary cells and batteries containing alkaline or other non-acid electrolytes - Part 2: Lithium systems) | Compliant (Differences in power source, patient leakage current, automatic no-load trip, and environmental conditions are noted as complying with this and other safety standards and not raising safety concerns.) |
| Biocompatibility | ISO 10993-5 (Tests for in vitro cytotoxicity) | Conformed |
| ISO 10993-10 (Tests for irritation and skin sensitization) | Conformed | |
| ISO 10993-23 (Tests for irritation) | Conformed (Material differences with predicate devices are stated to not raise safety or effectiveness issues due to compliance with ISO 10993 series and similar contact category/duration.) | |
| Software Verification & Validation | FDA Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Software concern level: Moderate, i.e., malfunction could lead to minor injury) | Software verification and validation testing were conducted and documentation was provided as recommended. |
| Usability | IEC 62366-1 (Application of usability engineering to medical devices) | Compliant |
| IEC 60601-1-6 (Usability – Collateral standard for medical electrical equipment and medical electrical systems) | Compliant |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "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." Therefore, there was no clinical test set for this submission. The data provenance is derived from engineering and physical testing against international standards in China, where the manufacturer is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable, as no clinical test set requiring expert ground truth was utilized. The "ground truth" for the non-clinical tests was defined by compliance with the referenced international standards.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a MRMC comparative effectiveness study was not done. The submission did not involve clinical studies with human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a physical skincare wand, not an algorithm, and its performance evaluation relies on physical and electrical safety testing rather than algorithmic accuracy.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on engineering and physical testing against established international safety and performance standards (e.g., IEC 60601-1, IEC 62471, ISO 10993 series). Claims of "substantial equivalence" rely on demonstrating that the device meets these standards and functions similarly to legally marketed predicate devices without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 13, 2023
Shenzhen Kaiyan Medical Equipment Co., Ltd Alain Dijkstra Official Correspondent Building#3 and Building#5, 40th of Fuxin Street Huaide Community Fuyong Town, Baoan District Shenzhen, 518103 China
Re: K232863
Trade/Device Name: Radiant Renewal Skincare Wand (HD-15, HD-15A) 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, NFO Dated: August 23, 2023 Received: September 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 (the 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/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}------------------------------------------------
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). 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 Digitally Digitally signed by Jianting Date: 2023.12.13 13:54:39 -2 -05'00'
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
{2}------------------------------------------------
OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
Indications for Use
510(k) Number (if known) K232863
Device Name
Radiant Renewal Skincare Wand (HD-15, HD-15A)
Indications for Use (Describe)
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over thecounter use.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{4}------------------------------------------------
510(k) Summary of K232863
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: Shenzhen Kaiyan Medical Equipment Co., Ltd Establishment Registration Number: 3011644607 Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Contact Person (including title): Alain Dijkstra (Manager) Tel: +86-135-10378748 Fax: +86-755-25024651 E-mail: requlation@kaiyanmedical.com
Application Correspondent:
Contact Person: Alain Dijkstra Company: Shenzhen Kaiyan Medical Equipment Co., Ltd Address: Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, Baoan District, Shenzhen, Guangdong 518103, China Tel: +86 755 82129361 Fax: +86 755 25024651 Email: regulation@kaiyanmedical.com
2. Subject Device Information:
Trade Name: Radiant Renewal Skincare Wand, model: HD-15, HD-15A Classification Name: Light based OTC for winkle reduction; Transcutaneous Electrical, Aesthetic Purposes Review Panel: General & Plastic Surgery Product Code: OHS, NFO Regulation Number:21 CFR 878.4810, 21 CFR 882.5890 Regulation Class: II
3. Predicate Device Information
Predicate Device 1 (K171821) Sponsor: Heat In A Click Trade Name: 2 Face / Face Evolution (Model: 2 Face / Face Evolution) Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes; Light Based Over the Counter Wrinkle Reduction, over-the counter powered light based laser for acne Review Panel: General & Plastic Surgery Product Code: NFO, OHS, OLP Regulation Number: 21 CFR 882.5890, 21 CFR 878.4810
Requlation Class: II
Predicate Device 2 (K212342)
Sponsor: ZIIP, Inc. Trade Name: ZIIP+ Device
{5}------------------------------------------------
Classification Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief. Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II
Predicate Device 3 (K163470)
Sponsor: ShenZhen Siken 3D Technology Development Co.,Ltd. Trade Name: Galvanic Spa Classification Name: stimulator, transcutaneous electrical, aesthetic purposes Review Panel: Neurology Product Code: NFO Regulation Number: 21 CFR 882.5890 Regulation Class: II
Predicate Device 4 (K202055)
Sponsor: Heat In A Click LLC Trade Name: Looper (Model: ZX-579S) Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over The Counter Wrinkle Reduction (OHS) Review Panel: General & Plastic Surgery Product Code: OLP, OHS Regulation Number: 21 CFR 878.4810 Regulation Class: II
4. Device Description
The Radiant Renewal Skincare Wand (Model: HD-15, HD-15A) is a hand-held, battery-powered device used to stimulate the face and neck superficially through application of transcutaneous electrical currents and treat wrinkles by emitting 630 nanometers of red light. The device is powered by a Lithium-lon rechargeable battery, and it has a charging cable, carrying case and instruction manual.
There are two models of the device, with only differences in operating modes. Model HD-15 only has a red-light wrinkle treatment effect, while Model HD-15A has two functional modes: one is red light wrinkle treatment, and the other is micro current stimulation of the face and neck.
Both of them have one button to turn on/off the device. For model HD-15A, this button also can switch the mode.
The device will automatically shut down after 12 minutes of operation. The recommended treatment time is 3 minutes. After every three minutes of treatment, the device will vibrate the time. If you need to continue treatment, simply turn on the device again.
5. Intended Use / Indications for Use
The Radiant Renewal Skincare Wand (Model: HD-15) is intended for treating wrinkles on the face and is indicated for over-the-counter use.
The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the-counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the-counter use.
6. Comparison to predicate devices
Compare with the predicate devices, the subject device is very similar in design principle, intended use,
{6}------------------------------------------------
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 ofComparison | Subjectdevice | Predicatedevice(K171821) | Predicate1 device(K212342) | Predicate2 device(K163470) | Predicate3 device(K202055) | 4 Remark |
|---|---|---|---|---|---|---|
| Manufacturer | ShenzhenKaiyanMedicalEquipmentCo., Ltd | Heat In AClick | ZIIP Inc. | ShenZhen Siken3D TechnologyDevelopmentCo., Ltd. | Heat In A ClickLLC | |
| 510Number | (K) K232863 | K171821 | K212342 | K163470 | K202055 | |
| Device Name | RadiantRenewalSkincareWand | 2 Face / FaceEvolution(Model:Face / FaceEvolution) | Micro-currentWrinkleReductionFacial Service | Galvanic Spa,Model:SKB-1405 | Looper | |
| OTC/Rx | OTC | OTC | OTC | OTC | OTC | Same |
| RegulationClass | Class II | Class II | Class II | Class II | Class II | Same |
| Product Code | NFO, OHS | NFO, OHS,OLP | NFO | NFO | OHS, OLP | Same |
| Mechanism ofAction | Microcurrentelectricaltherapy todeliver skinstimulation;Red lighttreatment forfacialwrinkles. | Microcurrentelectricaltherapy todeliver skinstimulation;Red lighttreatment forfacial wrinkles;Bule lighttreatment formild tomoderateinflammatoryacne. | Microcurrentelectricaltherapy todeliver skinstimulation | Microcurrentelectrical therapyto deliver skinstimulation | Blue light therapyfor mild tomoderateinflammatoryacne;Red lighttreatment forfacial wrinkles. | Same |
| RegulationNumber | 21 CFR882.5890,21 CFR878.4810 | 21 CFR882.5890,21 CFR 878.4810 | 21 CFR882.5890 | 21 CFR882.5890 | 21 CFR878.4810 | Same |
| Indications forUse / Intendeduse | The RadiantRenewalSkincareWand(Model: HD-15) isintended fortreatingwrinkles onthe face and | 2 Face / FaceEvolution is ahand-helddevice forover-thecounteraestheticpurposes.(1) The EMSmode isindicatedfor | The ZIIP+Device isintended forfacial and neckstimulation andis indicated forover-the-counter use. | The GalvanicSpa (Model:SKB-1405) isintended forfacial stimulationand is indicatedfor over-thecounter cosmeticuse. Theanatomical site | Looper (Model:ZX-579S) is ahand-held devicefor over-thecounter aestheticpurposes. ThePhoton mode redlight is indicatedfor the use intreating wrinkleson the face, and | Same |
| Elements of Comparison | Subject device | Predicate device (K171821) | Predicate 1 device (K212342) | Predicate 2 device (K163470) | Predicate 3 device (K202055) | 4 Remark |
| is indicated for over-the- counter use. The Radiant Renewal Skincare Wand (Model: HD-15A) is intended for facial and neck stimulation and is indicated for over-the- counter cosmetic use, the red light is intended for treating wrinkles on the face and is indicated for over-the- counter use. | facial stimulation; (2) The Photon mode: 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 inflammatory acne. | the Galvanic Spa is the face. | the blue light is indicated for the treatment of the mild to moderate inflammatory acne. | |||
| Material/ Biocompatibility | PC and Aluminum | ABS Plastic & Stainless Steel | Biocompatible materials typically used in medical devices and identical to predicate ZIIP device | Stainless steel | ABS Plastic & Stainless Steel | & Different , note 1 |
| Power Source | Lithium battery: 3.7V, 500mAh, 1.85Wh | DC 2200mAh | 3.7V Internal Rechargeable Lithium Ion Battery | 3.7V Li-battery | DC 3.7V 1000mA Li battery | Different , note 2 |
| Sterility | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Not applicable – this device is not sold sterile | Same |
| Human Factors | Hand-held device | Hand-held device | Hand-held device | Hand-held device | Hand-held device | Same |
| Electrical Safety | Compliant with | Compliant with | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | Compliant with IEC 60601-1 | Same |
| Elements ofComparison | Subjectdevice | Predicatedevice 1(K171821) | Predicatedevice(K212342) | Predicate2 device(K163470) | Predicate3 device(K202055) | 4 Remark |
| 60601-1,IEC 60601-1-2,IEC 60601-1-11,IEC 62471,IEC 60601-2-10,IEC 60601-2-57 | 60601-1,IEC 60601-1-2,IEC 62471,IEC 60601-2-57 | IEC 60601-1-2,IEC 60601-1-11 | IEC 60601-1-2,IEC 60601-2-10 | 60601-1-2,60601-1-11,62471,60601-2-57 | IEC | |
| Type ofEnergy | LED,Electricalcurrent | LED,Electricalcurrent | Electricalcurrent | Electricalcurrent | LED | Same |
| ChargingMethod | External walladaptor | External walladaptor | External walladaptor | External walladaptor | No publicity | Same |
| Detailed Output Characteristics | ||||||
| PowerSource(s) | -- | -- | -- | -- | -- | -- |
| a) Method ofLine CurrentIsolation | OnerechargeableLithium-IonBattery andExternalChargerIsolation | OnerechargeableLithium-IonBattery andExternalChargerIsolation | OnerechargeableLithium-IonBattery andExternalChargerIsolation | OnerechargeableLithium-IonBattery andExternal ChargerIsolation | Type BF | Same |
| b) PatientLeakageCurrent | -- | -- | ExternalChargerIncluded | -- | No publicity | -- |
| - NormalCondition | ≤100μΑ | No publicity | 46 μΑ | No publicity | No publicity | Different, note 2 |
| - FaultCondition | ≤500μΑ | No publicity | 46 μΑ | No publicity | No publicity | Different, note 2 |
| Number ofOutputModules | 1 | 2 | 1 | 1 | Not applicable | Same |
| Number ofOutputChannels | 1 | 2 | 1 | 1 | Not applicable | Same |
| a)Synchronousor Alternating | N/A – 1OutputChannel | No publicity | N/A – 1 OutputChannel | Alternating | Not applicable | Same |
| b) Method ofChannelIsolation | N/A – 1OutputChannel | Type BF | N/A - 1 OutputChannel | No publicity | Not applicable | Same |
| RegulatedCurrent orRegulatedVoltage | Both | Both | Both | Both | Not applicable | Same |
| Software/ | Yes | Yes | Yes | Yes | Yes | Same |
| Elementsof Comparison | Subjectdevice | Predicatedevice(K171821) | Predicatedevice(K212342) | Predicatedevice(K163470) | Predicatedevice(K202055) | Remark |
| Firmware/MicroprocessorControlled | ||||||
| AutomaticOverload Trip | Yes | No | Not requiredbecause ofcircuit design(Current andVoltageLimited byCircuit Designand Firmware) | Yes | Not applicable | Same |
| Automatic No-Load Trip | No | Yes | Yes(Reversion toFixed VoltageOutput) | Yes | Not applicable | Different,note 2 |
| AutomaticShut Off | Yes | Yes | Yes | Yes | Yes | Same |
| PatientOverrideControl | Yes | Yes | Yes | Yes | Yes | Same |
| Indicator Display | ||||||
| a)On/OffStatus | Yes | Yes | Yes(LEDIllumination onConduction) | Yes | Yes | Same |
| b) Low Battery | Yes | Yes | Yes | No | Yes | Same |
| c)Voltage/CurrentLevel | Yes | Yes | Yes(LEDIllumination onTarget CurrentLevels) | Yes | Yes | Same |
| Output Specifications | ||||||
| Waveform | PulsedBiphasic | PulsedBiphasic,ModulatedSquare | PulsedBiphasic | Pulsed Biphasic | Not applicable | Same |
| Shape | Rectangular | Rectangular | ModulatedSquare Wave | Symmetricbiphasic,rectangular | Not applicable | Same |
| MaximumOutput Voltage | $164 mV @ 500Ω$$540 mV @ 2kΩ$$2.28V @ 10kΩ$ | $310mV @ 500Ω$$1.16V @ 2kΩ$$5.56V @ 10kΩ$ | $154 mV @ 500Ω$$465 mV @ 2kΩ$$2.2 V @ 10kΩ$ | $156mV @ 500Ω$$0.78V @ 2kΩ$$2.6V @ 10kΩ$ | Not applicable | Similar,note 3 |
| MaximumCurrentDensity | $328 μA @ 500Ω$$270 μA @ 2kΩ$ | $620μA @ 500Ω$$580μA @ 2kΩ$ | $309 μA @ 500Ω$$232 μA @ 2kΩ$ | $0.31mA @ 500Ω$$0.39mA @ 2kΩ$$0.26mA @ 10kΩ$ | Not applicable | Similar,note 3 |
| Elements of Comparison | Subject device | Predicate device (K171821) | Predicate 1 device (K212342) | Predicate 2 device (K163470) | Predicate 3 device (K202055) | 4 Remark |
| 228 μA @ 10kΩ | 10kΩ | 10kΩ | ||||
| Frequency range | 10.5Hz | 8.333Hz | No publicity | 9.09 Hz±10 % | Not applicable | Similar, note 3 |
| Pulse duration | 48ms±10% | 60ms | No publicity | 55 ms | Not applicable | Similar, note 3 |
| Maximum Phase Charge | 15.74 μC@ 500Ω | 26.31μC @ 500Ω | 6.16 μC@ 500Ω | 17.1 μC @ 500Ω | Not applicable | Similar, note 3 |
| Maximum Current Density | 0.10 mA/cm²@ 500Ω | 0.330mA/cm² @500Ω | 0.34 mA/cm²@ 500Ω | 0.274mA/cm²@50Ω (The Electrode Size: 1.13 cm²) | Not applicable | Similar, note 3 |
| Maximum Power Density | 0.004 mW/cm²@ 500Ω | 4.34μW/cm² @500Ω | 3.44 W/ cm²@ 500Ω | 42.5μW/cm²@50Ω (The Electrode Size:1.13cm²) | Not applicable | Similar, note 3 |
| ON time | Constant | Constant | Constant | Adjustable, due to different levels | Not applicable | Same |
| OFF time | None | None | None | Adjustable, due to different levels | Not applicable | Same |
| Burst Mode (i.e. pulse trains) | N/A - no burst mode | No publicity | N/A - no burst mode | No publicity | Not applicable | Same |
| LED output Specification | ||||||
| LED wavelength | Red: 630nm ± 10nm | Red: 630 ± 3nm, Blue: 415 ± 3nm | Not applicable | Not applicable | Red: 630 ± 10nm, Blue: 415 ± 10nm | Same |
| Irradiances | 55mW/cm² ± 10% | Red light: 73.26mw/cm² ± 10% Blue: 64.10mw/cm² ± 10% | Not applicable | Not applicable | Red light: 55mw/cm² ± 10% Blue: 65mw/cm² | Similar, note 4 |
| LED output Specification | ||||||
| Environment for operating | Temperature: 0-30°C Humidity: 30-95% Atmospheric Pressure: 700hPa-1060hPa | No publicity | Temperature: 5 ~ 40° C | Temperature: 5°C~40°C Humidity: ≤80 % | Temperature: 0-30°C Humidity: 30-95% Atmospheric Pressure: 700hPa-1060hPa | Different, note 2 |
| Environment for storage | Temperature: -5-55 °C Humidity: | No publicity | Temperature: 25 ~70° C Humidity: | Temperature:0~ 45°C Humidity: < | Temperature: -5-55°C | Different, note 2 |
| Elementsof Comparison | Subjectdevice | Predicatedevice(K171821) | Predicate1 device(K212342) | Predicate2 device(K163470) | Predicate3 device(K202055) | 4 Remark |
| 20-95%AtmosphericPressure:700hPa-1060hPa | ~90% RH | ≤93% | Humidity:20-95%AtmosphericPressure:700hPa-1060hPa |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
Comparison in Detail(s):
Note 1:
Although the "Material/Biocompatibility" is different from the predicate devices, both have the same contact category and duration, and all of them complied with the ISO 10993 series standards' requirements. So, these differences will not raise any safety or effectiveness issues.
Note 2:
Although the "Power Source", "Patient Leakage Current under", "Normal Condition", "Automatic No-Load Trip", "Environment for operating" and "Environment for storage" are a little different from the predicate devices, they all complied with the IEC 60601-1, IEC 60601-1-2 and IEC 62133-2 safety standards' requirements. So, these differences will not raise any safety or effectiveness issues.
Note 3:
Although the "Maximum Output Voltage", "Maximum Current Density", "Frequency range" "Pulse duration", "Maximum Phase Charge", "Maximum Current Density" and "Maximum Power Density" of subject device are a little different from the predicate devices, they all comply with IEC 60601-2-10 safety standards' requirements, So, these differences will not raise any safety or effectiveness issues.
Note 4:
Although the "Irradiances" of subject device is a little different from the predicate devices, the values are similar and there are many similar devices market with the same treatment wavelength and Irradiance for the same intended purpose. Besides, both of the subject device and predicate device comply with IEC 60601-1, IEC 60601-2-57 safety standards' requirements, So, these differences will not raise any safety or effectiveness issues.
7. Test Summary
7.1 Non-Clinical Tests Performed
1) Electrical safety, and electromagnetic compatibility Test
Non-clinical tests were performed on the subject device for validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 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.
{12}------------------------------------------------
- � 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 60601-2-10 Edition 2.1 2016-04 Medical electrical equipment - Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators
2) Biocompatibility Test
The component of the Radiant Renewal Skincare Wand (Models: HD-15A) has been conformed to ISO 10993-5, ISO 10993-10 and ISO 10993-23.
3) Software verification and validation
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 validation
Usability testing was conducted on the Radiant Renewal Skincare Wand (Models: HD-15, HD-15A), 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: December 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 K171821, K212342, K163470 and K202055.
§ 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.