(184 days)
The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy . Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
The provided document is a 510(k) summary for the Aimanfun Lumea Comfort (Model: A-2788) device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed primary study data for specific acceptance criteria.
Therefore, the document does not contain the specific acceptance criteria and detailed study results in the manner typically found in a clinical study report. Instead, it relies on comparisons to predicate devices and adherence to recognized standards to support safety and effectiveness.
However, based on the information provided, here's a breakdown of what can be extracted and what is missing:
Description of Device and Intended Use:
The Aimanfun Lumea Comfort (Model: A-2788) is a light-based device intended for patient removal of unwanted hair using selective photothermal treatment under the direction of a physician, after training by a healthcare professional. It is also intended for permanent reduction in unwanted hair, defined as a long-term stable reduction in hair regrowth measured at 6, 9, and 12 months post-treatment regimen completion.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state acceptance criteria in a quantitative table format for performance. Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with recognized standards. The "performance" is implicitly demonstrated through the comparison table and the conclusion of substantial equivalence.
Implied Performance Parameters and Comparison to Predicates (from the "Comparison to Preadicate device and conclusion" table):
| Element of Comparison | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Aimanfun Lumea Comfort) | Remarks (Extracted from Notes) |
|---|---|---|---|
| Indications for Use | Similar to Predicate I, IV (Permanent hair reduction at 6, 9, 12 months intervals) | Permanent reduction in unwanted hair, measured at 6, 9, and 12 months after treatment regimen completion. | SE Note 1: Consistent with Predicate IV (K132170) for prescription use. |
| IFU Type | Prescription use (Predicate IV) or OTC (Predicates I, II, III) | Prescription use | SE Note 2: Intended for prescription use to mitigate misuse on inappropriate skin tones, consistent with K132170 (Predicate IV). |
| Regulation Number | 878.4810 (All Predicates) | 878.4810 | SE (Substantially Equivalent) |
| Classification Product Code | OHT or ONF (Predicates) | ONF | SE |
| Device Type | Intense Pulsed Light (All Predicates) | Intense Pulsed Light | SE |
| Power Source | AC Mains, external power supply, battery charger | An external power supply | SE |
| Light Source | Xenon Arc Flashlamp (All Predicates) | Xenon Arc Flashlamp | SE |
| Wavelength | Ranges from 400nm-1200nm (Predicates) | 475nm~1200nm | SE |
| Spot Size | Ranges from 2 cm² to 4.5 cm² (Predicates) | 3.0 cm² | SE |
| Max. Fluence (J/cm²) | Ranges from 3-10 J/cm² (Predicates) | 4.5 J/cm² | SE |
| Pulse Duration | Ranges from 2-13 milliseconds (Predicates) | 3 milliseconds | SE Note 3: Covered by Predicate I (2-10ms) range. Photothermolysis depends on pulse output energy. |
| Output Energy | Ranges from 6-22 J (Predicates) | 7-13.5 J | SE Note 4: Lowest level (7J) covered by Predicate III (6-13.5J). |
| Pulsing Control | Finger switch (All Predicates) | Finger switch | SE |
| Delivery Device | Direct Illumination to Tissue (All Predicates) | Direct Illumination to Tissue | SE |
| Software Control | Yes (All Predicates) | Yes | SE |
| Compliance with Standards | IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 60601-1-11, IEC 62471, ISO 10993-5, ISO 10993-10 | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57, ISO 10993-5, ISO 10993-10 | SE (All standards are met as per the test summary) |
2. Sample Size for the Test Set and Data Provenance:
The document does not report specific sample sizes for a clinical test set for demonstrating device performance. This 510(k) submission relies on bench testing, comparison to predicate devices, and adherence to performance standards. There is no mention of human subject testing data for the Aimanfun Lumea Comfort device itself within this summary.
Therefore, questions regarding data provenance (country of origin, retrospective/prospective) are not applicable from the given text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Since there is no reported clinical test set data from human subjects for the Aimanfun Lumea Comfort in this document, there is no information on experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set:
As there is no reported clinical test set data from human subjects, there is no mention of an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done or reported in this document. This submission is for a medical device (hair removal system), not an AI-assisted diagnostic tool where such studies are common. Therefore, information on the effect size of human readers with vs. without AI assistance is not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
The Aimanfun Lumea Comfort is a physical device (IPL hair removal system), not a software algorithm. Therefore, a standalone algorithm performance study is not applicable to this device. Its "performance" refers to its physical characteristics and effectiveness in hair removal, which is implicitly supported by its substantial equivalence to predicate devices and compliance with safety standards.
7. Type of Ground Truth Used:
For this mechanical/electrical device, the "ground truth" for its safety and claimed performance (hair reduction) is implicitly established through:
- Engineering specifications and measurements: Bench testing for electrical safety, EMC, output energy, wavelength, etc., as per recognized standards (IEC, ISO).
- Comparison to legally marketed predicate devices: The functionality and expected outcome (hair reduction) are benchmarked against devices previously cleared by the FDA, using their established indications for use and performance parameters as a basis for substantial equivalence.
- Adherence to recognized standards: Compliance with standards like ISO 10993 for biocompatibility (cytotoxicity, sensitization, irritation) ensures the materials are safe for patient contact, which acts as a form of "ground truth" for material safety.
There is no mention of pathology, outcomes data from a prospective study for this specific device, or expert consensus on clinical images in this 510(k) summary.
8. Sample Size for the Training Set:
This device does not involve a "training set" in the context of machine learning or AI algorithms. It's an Intense Pulsed Light (IPL) device. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established:
Since there is no "training set" for this device (as it's not an AI/ML algorithm), this question is not applicable.
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Image /page/0/Picture/0 description: The image contains 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, 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.
October 2, 2019
Kam Yuen Plastic Products Ltd % Jet Li Regulation Manager Guangzhou KEDA Biological Tech Co., Ltd. 6F. No.1 TianTai road, Science City, LuoGang District Guangzhou, Cn
Re: K190820
Trade/Device Name: Aimanfun Lumea Comfort 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: ONF Dated: March 24, 2019 Received: April 1, 2019
Dear Jet Li:
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 Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190820
Device Name
The Aimanfun Lumea Comfort (Model: A-2788)
Indications for Use (Describe)
The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician, after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
| 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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K190820 510(k) Summary
Date of the summary prepared: October 2, 2019
510(k) Summary
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
- � Company Name: Kam Yuen Plastic Products Ltd
- � Address: No. 2, Heng Feng Two Road, Pu Jin Industrial, Konghou Town, ZhongShan, Guangdong, China
- Phone: 86- 400- 962- 1668 �
- � Fax: 86-0760- 8841- 3080
- � Contact Person (including title): Anna Dan
- � E-mail:kamyuen@kyplastic.com
Application Correspondent:
- Company: Guangzhou KEDA Biological Tech Co., Ltd. �
- Address: 6F, No.1 TianTai road, Science City, LuoGang District, GuangZhouCity,China �
- � Contact Person: Mr. Jet Li
- � Tile: Regulation Manager
- � Tel: +86-18588874857
- � Email: med-jl@foxmail.com
2. Subject Device Information
- � Trade Name: Aimanfun Lumea Comfort, Model: A-2788
- Light based hair removal devices � Common Name:
- Powered Light Based Non-Laser Surgical Instrument With Classification name: �
- Thermal Effect
- General & Plastic Surgery � Review Panel:
- ONF � Product Code:
- 2 � Regulation Class:
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878.4810 � Regulation Number:
3. Predicate Device Information
Predicate device I - IV:
| Sponsor | CyDen Limited | Shen ZhenCosBeautyCo., Ltd | ConairCorporation | Shaser,Inc. |
|---|---|---|---|---|
| Device Name | iPulse SmoothSkinGold Hair RemovalSystem | Perfectsmooth | LumilisseIPL HairRemover | Shaser V-MINI RX |
| 510(k) Number | K160968 | K161428 | K172791 | K 132170 |
| Product Code | OHT | OHT | OHT | ONF |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 | 878.4810 |
| Regulation Class | Class II | Class II | Class II | Class II |
4. Device Description
Aimanfun Lumea Comfort, Model: A-2788 is a light-based device for long-term hair removal. It is intended for the removal of unwanted hair and permanent reduction in hair regrowth. Ideal body areas include the underarms, bikini line, arms and legs. The device used the IPL technology with lower energy level, including 5 Levels of output energy . Intense Pulsed light technology is able to achieve long-term hair removal results at a fraction of the energy level used in other light-based hair removal equipment. The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse Light (IPL) technology. The purpose of the light is to heat the root where the hair grows. The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
5. Intended Use / Indications for Use
The Aimanfun Lumea Comfort (Model: A-2788) is indicated for patient removal of unwanted hair by using a selective photothermal treatment under the direction of a physician,after training by a healthcare professional. The Aimanfun Lumea Comfort is also intended for permanent reduction in unwanted hair.
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| Sponsor: | Kam Yuen Plastic Products Ltd |
|---|---|
| Subject Device: | Aimanfun Lumea Comfort, Model: A-2788 |
| File No.: | 510(k) submission report (V1.0), Chapter 6 510(k) Summary |
Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6. 9. and 12 months after the completion of a treatment regimen.
6. Design
Hand-held IPL device (Aimanfun Lumea Comfort) consists of main unit and adaptor. It is a portable device for the permanent reduction of hair growth based on Intense Pulsed Light (IPL) which is a xenon lamp.
The size of the device is about 138.98247.3mm (H x W x D). The device incorporates Intense Pulse
Light (IPL) technology. The purpose of the light is to heat the root where the hair grows.
The device contains a Xenon Lamp and a skin proximity sensor to detect appropriate skin contact. If the
IPL Hair Removal Device is not properly applied to the treatment area (in full contact with the skin), the device cannot be triggered a pulse emitting.
7. Materials
There is one part of patient directly contacting component in the subject device as the following list.
| Component ofDevice RequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| Housing of unit | ABS | Surface-contactingdevice: skin | Maximum 30minutes(< 24hours) |
The Nature of body contact is surface, skin contact. And the contact duration is less than 24 hours. According to Table 1 - Initial evaluation tests for consideration in ISO 10993-1, the applicable biological effect is:
- � Cytotoxicity
- � Sensitization
- � Irritation or intracutaneous reactivity
8. Physical characteristics
| Basic Unit Characteristics | |
|---|---|
| Compliance* with 21 CFR 898 | No |
| Main Unit Weight | 200g |
| Main Unit Dimension | 138.98247.3mm |
| Housing Materials of main unit | ABS |
| Indicator | Indicates power information/skin detectioninformation, gear conversion information. |
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Kam Yuen Plastic Products Ltd Sponsor: Subject Device: Aimanfun Lumea Comfort, Model: A-2788 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
| Time Range (minutes) | Work for 60 minutes and stop for 10 minutes |
|---|---|
| Environment for operation | Temperature: 5°C |
| Storage and Transport Conditions | Temperature: 0°C |
| Compliance with VoluntaryStandards | Yes, Comply with IEC 60601-1, IEC 60601-1-2,IEC 60601-2-57 . |
| Patient leakage current | Comply with IEC 60601-1 |
| Power Source | Supplied by external adapter |
| Software/Firmware/MicroprocessorControl? | Yes |
| Specification | |
| Output Intensity Level | 5 steps |
| Output energy | 7-13.5J |
| Emitted Light Spectrum | 475nm~1200nm Max |
| Pulse width range | 3 ms |
| Power Supply | 100-240 VAC, 50/60Hz, 0.5A |
| Technology | IPL |
9. Test Summary
Aimanfun Lumea Comfort, Model: A-2788 has been evaluated the safety and performance by lab bench testing as following:
IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 2012 +A1:2012
IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2014
IEC 60601-1-11:2015 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 60601-2-57:2011 Medical electrical equipment –Part 2-57: Particular requirements for the basic safety and essential performance of non-laser source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use
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ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff
10. Comparison to predicate device and conclusion
The technological characteristics, features, specifications, materials, and intended use of Aimanfun Lumea Comfort, model: A-2788 is substantially equivalent to the predicate devices quoted above. Aimanfun Lumea Comfort relies on the same technology as both predicate devices : Intense Pulsed Light (IPL). Their energy source is the same: Xenon Arc Flashlamp.
The safety and efficacy of IPL treatment for hair reduction are governed by the following parameters:
• Wavelength of the emitted light (spectrum): Defines the interaction with specific chromophores (the part of the molecule responsible for its color) such as melanin, hemoglobin and water. Aimanfun Lumea Comfort and the predicate devices utilize the same spectrum as the Perfectsmooth predicate device (475-1200nm).
• Fluence/flux - defines the energy per area (e.g. joules per cm²) for the treatment. Aimanfun Lumea Comfort and the predicate devices deliver the same maximum energy (4.5 joules/cm2).
The following technological differences exist between the subject and predicate devices I to III:
- Prescription use for subject device:
- । No Skin tone sensing circuit; but subject device and predicate devices IV is the same design on this feature and both of them are also for prescription use.
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
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| Elements ofComparison | Subject Device | Primary PredicateDevice I | Predicate DeviceII | Predicate DeviceDevice III | PredicateDevice IV | Verdict |
|---|---|---|---|---|---|---|
| Manufacturer | Kam Yuen PlasticProducts Ltd | CyDen Limited. | Shen ZhenCosBeauty Co.,Ltd | ConairCorporation | Shaser, Inc. | -- |
| Product Name | Aimanfun LumeaComfort, Model: A-2788 | iPulse SmoothSkinGold Hair RemovalSystem | Perfectsmooth | Lumilisse IPLHair Remover | Shaser V-MINIRX | -- |
| 510(K) No. | Applying | K160968 | K161428 | K172791 | K 132170 | -- |
| IndicationsforUse | The Aimanfun LumeaComfort (Model: A-2788) is indicated forpatient removal ofunwanted hair by usinga selectivephotothermaltreatment under thedirection of aphysician, aftertraining by ahealthcareprofessional. TheAimanfun LumeaComfort is alsointended forpermanent reduction inunwanted hair.Permanent hairreduction is defined asthe long-term stablereduction in thenumber of hairs | The iPulseSmoothSkin GoldHair RemovalSystem is indicatedfor the removal ofunwanted hair. TheiPulse SmoothSkinGold is alsoindicated for thepermanentreduction in hairregrowth, defined asthe long-term,stable reduction inthe number of hairs | The IPL HairRemoval DeviceJoy Version is anover-the-counterdevice intended forremoval ofunwanted hairsuch as but notlimited to smallareas such asunderarm andfacial hair belowthe chin line andlarge areas suchas legs. | The Lumilisse IPL(Intense PulsedLight) HairRemover is anover-the-counterdevice intendedfor the removal ofunwanted hair. | The Shaser V-MINI RN HairRemoval Systemis intended toprovidephototherapeuticlight to the bodyand is generallyindicated to treatdermatologicalconditions. It isalso intended forremoval ofunwantedhair by using aselectivephotothermaltreatment. TheShaser V-MINIRN Hair RemovalSystem isindicated forpatient removal of | SENote 1 |
| Elements ofComparison | Subject Device | Primary PredicateDevice I | Predicate DeviceII | PredicateDevice III | PredicateDevice IV | Verdict |
| regrowing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen. | regrowing whenmeasured at 6, 9and 12 months afterthe completion of atreatment regime. | unwanted hair byusing a selectivephotothermaltreatment underthe direction of aphysician. aftertraining by ahealthcareprofessional. Itis also indicatedfor the removal ofunwanted bodyand/or facial hairin adults withFitzpatrick skintypes I - VI. TheShaser V-MINIRX Hair RemovalSystem is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as thelong-termstable reductionin the number ofhairs regrowingwhen measuredat 6, 9, and 12months after thecompletion of a | ||||
| Elements ofComparison | Subject Device | Primary PredicateDevice I | Predicate DeviceII | PredicateDevice III | PredicateDevice IV | Verdict |
| treatmentregimen. | ||||||
| IFU Type | Prescription use | Over-The-Counter | Over-The-Counter | Over-The-Counter | Prescription use | SENote 2 |
| ClassificationProduct Code | ONF | OHT | OHT | OHT | ONF | SE |
| Device Type | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense PulsedLight | SE | |
| Device Design | ||||||
| Power source | an external powersupply | AC Mains | an external powersupply | an external powersupply | Battery charger | SE |
| Light source | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | SE |
| Wavelength | 475~1200nm | 510nm~1100nm | 475nm~1200nm | 550-1200 nm | 400~1200nm | SE |
| Spot Size | 3.0 cm2 | 3 cm2 | 4.5 cm2 | About 3 cm2 | 2 cm2 | SE |
| Max. Fluence(J/cm²) | 4.5 J/cm² | 3-6 J/cm² | 4.7 J/cm² | 4.5 J/cm² | 6-10 J/cm² | SE |
| Pulse duration | 3 milliseconds | 2-10 milliseconds | 11-13 milliseconds | - | - | SE |
| Elements ofComparison | Subject Device | Primary PredicateDevice I | Predicate DeviceII | PredicateDevice III | PredicateDevice IV | Verdict |
| Note 3 | ||||||
| Output energy | 7-13.5 J | 9-18 J | < 22 J | 6-13.5 J (basedon its lightintensity 2.0 J cm²-4.5 J/cm²) | < 20 J | SENote 4 |
| Pulsing Control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | SE |
| Delivery Device | Direct Illumination toTissue | Direct Illumination toTissue | Direct Illumination toTissue | Direct Illuminationto Tissue | Direct Illuminationto Tissue | SE |
| SoftwareControl | Yes | Yes | Yes | Yes | Yes | SE |
| FDA-Recognized Standards | ||||||
| IEC 60601-1 | IEC 60601-1 | |||||
| IEC 60601-1 | IEC 60601-1 | IEC 60601-1 | IEC 60601-1-2 | IEC 60601-1-2 | ||
| Electricalsafety, EMC, | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-2-57 | IEC 60601-2-57 | |
| BiologicalEvaluation | IEC 60601-1-11 | IEC 62471 | IEC 60601-2-57 | IEC 62471 | IEC 62471 | SE |
| IEC 60601-2-57 | ISO 10993-5 | IEC 62471 | ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-5 | ISO 10993-10 | ISO 10993-5 | ISO 10993-10 | ISO 10993-10 | ||
| ISO 10993-10 | ISO 10993-12 | ISO 10993-10 |
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Sponsor: Kam Yuen Plastic Products Ltd
Subject Device: Aimanfun Lumea Comfort, Model: A-2788
File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
{10}------------------------------------------------
Sponsor: Kam Yuen Plastic Products Ltd Subject Device: Aimanfun Lumea Comfort, Model: A-2788 File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
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Sponsor: Kam Yuen Plastic Products Ltd
Subject Device: Aimanfun Lumea Comfort, Model: A-2788
File No.: 510(k) submission report (V1.0), Chapter 6 510(k) Summary
{12}------------------------------------------------
Comparison in Detail(s):
Note 1
Although there is difference about Type of use between Subject device and Predicate device I to III and provide addtional description for using direction requirement that a selective photothermal treatment under the direction of a physician,after training by a healthcare professional. But the type of use of Aimanfun Lumea Comfort is same to predicate device IV(K132170). This difference does not affect the safety and effectiveness.
Note 2
Based on considering mitigates the possibility of intentional misuse of the device on inappropriate skin tones, the subject device was intended to be prescription use for its IFU, referring to K132170. This difference does not affect the safety and effectiveness.
Note 3
Although the pulse duration is minor different to predicate device K161428 Shen Zhen CosBeauty Co., Ltd; but in the predicate device K160968 CyDen Limited, its pulse duration is 2-10 milliseconds, which can cover the pulse duration of 3 ms in subject device. And the photothermolysis treatment mainly is depended on its pulse output energy. and subject device's output energy is substantial equivalent to others predicate device. So the minor difference on pulse duration do not affect the safety and effectiveness.
Note4:
The output energy of subject device is design to be 7- 13.5 J based on its level 1-5; there is minor difference on output energy for the lowest level 1) between subject device and the predicate device K160968 CyDen Limited(9 J); but the lowest level energy also was covered in the output energy range of predicate device III K172791 Conair Corporation. , so the differences do not affect the safety and effectiveness.
Conclusion:
The subject device "Aimanfun Lumea Comfort, Model: A-2788" is substantial Equivalence to all predicate devices.
§ 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.