(147 days)
IPL home use hair removal device 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 IPL home use hair removal device 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.
The device is used for adults with Fitzpatrick skin types I - IV.
The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse.
The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.
FZ-608 and FZ-608G are identical except for model No. and enclosure colour.
The patient is an intended operator.
The provided document is a 510(k) Premarket Notification for a Hand-held IPL device (IPL Home Use Hair Removal Device). This document is primarily concerned with demonstrating substantial equivalence to predicate devices, not with establishing acceptance criteria for a new and novel device, nor does it detail a study proving the device meets specific acceptance criteria related to efficacy beyond showing similarity to already cleared devices.
Therefore, the information required to answer your prompt thoroughly, particularly regarding a multi-reader multi-case (MRMC) comparative effectiveness study, human expert involvement in ground truth, sample sizes for training/test sets for a novel AI algorithm, and quantitative metrics of device performance against specific acceptance criteria, is not present in this type of regulatory submission.
The document discusses performance data in a general sense, focusing on:
- Biocompatibility testing: Cytotoxicity, Sensitization, Irritation. These are related to safety of materials in contact with the skin.
- Electrical safety and electromagnetic compatibility (EMC) testing: Compliance with standards like AAMI/ANSI ES60601-1, IEC 60601-2-83, and IEC 60601-1-2. These relate to electrical safety and electromagnetic interference.
- Software Verification and Validation Testing: Standard V&V for software, with a "Moderate" level of concern.
- Bench Testing: Verification of parameters like wavelength, pulse duration, output energy, and maximum fluence against design specifications and comparison to predicate devices. This is to show the device operates as intended and is similar to predicates.
The "Performance Data" section (Section 7) describes general testing conducted to support substantial equivalence, but it does not provide the kind of detailed study data (like sensitivity, specificity, or improvement over human readers) that would be expected for an AI/ML-based medical device. The "Indications for Use" section focuses on permanent hair reduction, defined by hair regrowth measurements at 6, 9, and 12 months, but the document does not present clinical study results to demonstrate this. Instead, it relies on the predicate devices having similar indications and technology.
Based on the provided document, here's what can be inferred or explicitly stated, with limitations:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria for clinical performance (e.g., specific hair reduction percentages) and reported device performance against those criteria. The "acceptance criteria" discussed are largely compliance with electrical safety, EMC, and biocompatibility standards, and demonstrating similar technical parameters to predicate devices.
The closest to "acceptance criteria" are the parameters verified by bench testing and their similarity to predicate devices. However, these are not clinical performance metrics.
| Parameter (Bench Testing) | Subject Device 1# (FZ-608 & FZ-608G) | Subject Device 2# (FZ-100) | Subject Device 3# (FZ-200) | Predicate Devices (Range) | Note/Remark |
|---|---|---|---|---|---|
| Wavelength (nm) | 510 - 1200 | 510 - 1200 | 510 - 1200 | 475 - 1200 | Similar |
| Spot size (cm²) | 3 | 3 | 3 | 3 - 3.3 | Similar |
| Max fluence (J/cm²) | 3.33 | 5.43 | 4.5 | 4.5 - 6 | Note 2# |
| Energy output (J) | 4.16 - 10 | 5.7 - 16.26 | 4.6 - 13.5 | 7 - 20 (max) | Similar |
| Energy density range (J/cm²) | 1.4 - 3.3 | 1.9 - 5.4 | 1.5 - 4.5 | 2.1 - 6 | Similar |
| Pulse duration (ms) | 0.5 - 0.8 | 0.5 - 0.8 | 0.5 - 0.8 | 0.5 - 10 | Similar |
2. Sample size used for the test set and the data provenance
The document does not describe a clinical "test set" in the context of an AI/ML device or a performance study with human participants. The testing mentioned (biocompatibility, electrical safety, bench testing) does not involve human sample sizes for a clinical performance evaluation of hair reduction efficacy. Data provenance is not applicable here as it's not a data-driven AI/ML model for diagnosis/prognosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There's no mention of experts establishing ground truth for a test set, as this is not a diagnostic/AI device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. There's no mention of a test set requiring adjudication.
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 device is an Intense Pulsed Light (IPL) device for hair removal, not an AI-assisted diagnostic or image interpretation tool. Therefore, an MRMC study is not relevant to this submission.
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.)
The document does not detail the establishment of "ground truth" for clinical efficacy of hair removal. For the device's stated purpose, "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." However, the 510(k) submission relies on substantial equivalence to predicate devices for this claim, rather than presenting a de novo clinical study with measured outcomes. The "ground truth" for the technical parameters is primarily the design specifications and measurements from the predicate devices.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" for machine learning.
In summary: This 510(k) submission for a Hand-held IPL device focuses on demonstrating substantial equivalence to already cleared predicate devices through technical comparisons, safety testing (biocompatibility, electrical safety, EMC), and software validation. It does not contain the detailed clinical performance study data that would be required for a novel AI/ML device, nor does it define or report against explicit clinical acceptance criteria using specific patient sample sizes or expert ground truth methods. The "performance data" refers to technical and safety compliance, not clinical efficacy metrics from a human study.
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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 on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 21, 2022
Shenzhen IONKA Medical Technology Co., Ltd. % Amos Zou RA Manager Shenzhen CT Bio-Tech co., Ltd Room 408, Comprehensive Building, Building 6, Xusheng Building, Xixiang street, Baoan District Shenzhen, Guangdong 518126 China
Re: K221214 Trade/Device Name: Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608, FZ-608G, FZ-100, FZ-200 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: May 31, 2022 Received: May 31, 2022
Dear Amos Zou:
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
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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 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 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 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) K221214
Device Name
Hand-held IPL device (IPL Home Use Hair Removal Device) Model:FZ-608,FZ-608G,FZ-100,FZ-200
Indications for Use (Describe)
IPL home use hair removal device 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 IPL home use hair removal device 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.
The device is used for adults with Fitzpatrick skin types I - IV.
| 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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Image /page/3/Picture/0 description: The image shows the text "TIANZHIWEIMEI" in black, with the Chinese characters for the same phrase above it. The Chinese characters are also in black and have a similar font style to the English text. The text is centered and appears to be a logo or brand name.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION as required by section 21 CFR 807.92
Submitter of 510(K): 1.
| Sponsor | |
|---|---|
| Company Name: | Shenzhen IONKA Medical Technology Co., Ltd. |
| Address: | Room 601, No. 3, Jiazitang Second Industrial Zone, Jiazitang Community, |
| Fenghuang Street, Guangming District, Shenzhen, 518132,China | |
| Contact person: | Mr. Chen Dongfa |
| TEL: | +86-755-23406031 |
| FAX: | +86-755-23406031 |
| E-mail: | info@tzwm.com |
| Date of Prepared: | August 31, 2022 |
Application Correspondent:
| Company Name: | Shenzhen CT Bio-Tech co., Ltd |
|---|---|
| Address: | Room 408,Comprehensive Building,Building 6,Xusheng Building,Xixiangstreet,Baoan District,Shenzhen,,Guangdong.518126,China |
| Contact person: | Amos Zou |
| TEL: | +86-15015249549 |
| E-mail: | amos.zou@139.com |
| Date of Prepared: | August 31, 2022 |
2. Proposed Device and code:
| Device Trade Name: | Hand-held IPL device (IPL Home Use Hair Removal Device)Model:FZ-608, FZ-608G, FZ-100, FZ-200 |
|---|---|
| Regulation Medical Specialty | General & Plastic Surgery |
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Image /page/4/Picture/1 description: The image shows the text "TIANZHIWEIMEI" in all caps, with Chinese characters above it. The font is a simple sans-serif style, and the text is horizontally centered. The image is in black and white, with the text appearing in black against a white background.
| Product Code: | ONF |
|---|---|
| Regulation Name | Laser surgical instrument for use in general and plastic surgery and in dermatology. |
| Common Name | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect |
| Regulation number | 21 CFR 878.4810 |
| Device Class | II |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| K160968 | Ipulse Smoothskin Gold Hair Removal Device | Cyden Limited |
| K170269 | Hee HR Mini | Oriental InspirationLimited |
| K213558 | IPL Hair Removal Device | Ulike Co., Ltd |
| K212907 | Aimanfun Lumea Comfort, A-3588 | Kam Yuen Plastic Products Ltd |
4. Description of Proposed Device:
The Hand-held IPL device are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photosynthesis in which optical energy is used to disable hair growth. The Hand-held IPL device devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the Hand-held IPL device devices is 3 cm², The device contains a lamp, a skin proximity sensor. If the Hand-held IPL device is not properly applied (in full contact with the skin) , the Hand-held IPL device will not trigger a pulse.
The main unit FZ-608 and FZ-608G can only be supplied by the power adaptor (model: SHCSP2402000FUS), The main unit FZ-100 and FZ-200 can only be supplied by the power adaptor (model: SHCY-SP2401500EUS), the adapters have been approved in accordance with IEC 62368-1 and tested with equipment, considering as a part of this ME equipment.
FZ-608 and FZ-608G are identical except for model No. and enclosure colour.
The patient is an intended operator.
న. Indications for Use
IPL home use hair removal device 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 IPL home use hair removal device 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. The device is used for adults with Fitzpatrick skin types I - IV.
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Image /page/5/Picture/0 description: The image shows the text "天之唯美" in a stylized font, with the English transliteration "TIANZHIWEIMEI" written below it in a smaller, sans-serif font. The Chinese characters are bold and have a modern, clean design. The overall composition is simple and clear, with a focus on the text itself.
Technical and Performance 6.
The following table compares the device to the predicate device with basic technological characteristics.
| Elements ofcomparison | Subject Device1# K221214 | Subject Device2# K221214 | Subject Device3# K221214 | Predicate Device1# K160968 | Predicate Device2# K170269 | Predicate Device3# K212907 | Predicate Device4# K213558 | Remark |
|---|---|---|---|---|---|---|---|---|
| DeviceName andModel | IPL home use hairremoval deviceFZ-608&FZ-608G | IPL home use hairremoval deviceFZ-100 | IPL home use hairremoval deviceFZ-200 | IpulseSmoothskinGold HairRemoval Device | Hee HR Mini | Aimanfun LumeaComfort, A-3588 | IPL HairRemoval Device | / |
| Manufacturer | Shenzhen IONKAMedical TechnologyCo., Ltd. | Shenzhen IONKAMedical TechnologyCo., Ltd. | Shenzhen IONKAMedical TechnologyCo., Ltd. | Cyden Limited | OrientalInspirationLimited | Kam YuenPlastic ProductsLtd | Ulike Co., Ltd | / |
| Classificationn ProductCode | ONF | ONF | ONF | OHT, GEX | OHT | ONF | ONF | Same |
| Light source | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Xenon ArcFlashlamp | Same |
| similar | ||||||||
| Wavelength(nm) | 510 - 1200 | 510 - 1200 | 510 - 1200 | 510 - 1100 | 475 - 1200 | 475 - 1200 | 550 - 1200 | Note 1# |
| Same | ||||||||
| Spot size | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3 cm2 | 3.3 cm2 | similar |
| Max fluence | 3.33 J/cm2 | 5.43 J/cm2 | 4.5 J/cm2 | 6 J/cm2 | 5 J/cm2 | 4.5 J/cm2 | 6 J/cm2 | Note 2# |
| Level 1: 4.16J | Level 1: 5.7J | Level 1: 4.6J | Similar | |||||
| Energyoutput | Level 2: 4.36JLevel 3: 5.1J | Level 2: 6.5JLevel 3: 8.06J | Level 2: 5.7JLevel 3: 6.63J | 9 - 18 J | 15 J max | 7 - 13.5 J | 7 – 20 J | |
| Elements ofcomparison | Subject Device1# K221214 | Subject Device2# K221214 | Subject Device3# K221214 | Predicate Device1# K160968 | Predicate Device2# K170269 | Predicate Device3# K212907 | Predicate Device4# K213558 | Remark |
| Level 4: 6.1JLevel 5: 6.96JLevel 6: 7.96JLevel 7: 8.63JLevel 8: 9.13JLevel 9: 10J | Level 4: 9.73JLevel 5: 11.96JLevel 6: 14.1JLevel 7: 15.13JLevel 8: 15.33JLevel 9: 16.26J | Level 4: 8.66JLevel 5: 11.3JLevel 6: 13.5J | Note 3# | |||||
| Energydensity range | $1.4 - 3.3 J/cm^2$ | $1.9 - 5.4 J/cm^2$ | $1.5 - 4.5 J/cm^2$ | $3 - 6 J/cm^2$ | Unknown | $2.3 - 4.5 J/cm^2$ | $2.1 - 6 J/cm^2$ | SimilarNote 4# |
| Pulseduration | 0.5 - 0.8 ms | 0.5 - 0.8 ms | 0.5 - 0.8 ms | 2 - 10 ms | 0.5 - 0.8 ms | 3 ms | 3 ms | similarNote 5# |
| Skin contactsensor | Yes | Yes | Yes | Yes | Yes | Yes | Yes | same |
| Coolingsystem | Yes (thermoelectriccooler) | Yes (thermoelectriccooler) | Yes (semiconductorrefrigeration sheet) | No | No | Yes(thermoelectriccooler) | No | same |
| Treatmentschedule | 1 X/week for 12weeks | 1 X/week for 12weeks | 1 X/week for 12weeks | 1 X/week for 12weeks | 1X every 2 weeksfor 4 treatments,1X every 4 weeksfor treatments 5-7,then as needed | 1 X/week for 12weeks | 1 X/week for 12weeks | Same |
| Useclassification | Rx | Rx | Rx | OTC | OTC | Rx | Rx | Same |
| Ice-sensingfunction | Yes | Yes | No | No | No | Yes | No | Same asK212907Note 6# |
| Elements ofcomparison | Subject Device1# K221214 | Subject Device2# K221214 | Subject Device3# K221214 | Predicate Device1# K160968 | Predicate Device2# K170269 | Predicate Device3# K212907 | Predicate Device4# K213558 | Remark |
| DeliveryDevice | Direct Illumination toTissue | Direct Illumination toTissue | Direct Illumination toTissue | DirectIllumination toTissue | DirectIllumination toTissue | DirectIllumination toTissue | DirectIllumination toTissue | same |
| PulsingControl | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | same |
| Skin ToneSensor | Optical MeasurementIntegral to device.Continuousmeasurement. | Optical MeasurementIntegral to device.Continuousmeasurement. | Optical MeasurementIntegral to device.Continuousmeasurement. | OpticalMeasurementIntegral todevice.Continuousmeasurement. | OpticalMeasurementIntegral to device.Continuousmeasurement. | OpticalMeasurementIntegral todevice.Continuousmeasurement. | OpticalMeasurementIntegral to device.Continuousmeasurement. | same |
| SpecificIndicationsforUse | IPL home use hairremoval device isindicated for patientremoval of unwantedhair by using aselectivephotothermaltreatment under thedirection of aphysician, aftertraining by ahealthcareprofessional. The IPLhome use hair | IPL home use hairremoval device isindicated for patientremoval of unwantedhair by using aselectivephotothermaltreatment under thedirection of aphysician, aftertraining by ahealthcareprofessional. The IPLhome use hair | IPL home use hairremoval device isindicated for patientremoval of unwantedhair by using aselectivephotothermaltreatment under thedirection of aphysician, aftertraining by ahealthcareprofessional. The IPLhome use hair | The iPulseSmoothSkinGold HairRemoval Systemis indicated forthe removal ofunwanted hair.The iPulseSmoothSkinGold is alsoindicated for thepermanentreduction in hairregrowth | HEE HR Mini isan over-the-counter deviceintended for theremoval ofunwanted hair.The HEE HR Miniis also intended forpermanentreduction in hairregrowth, definedas a long-term,stable reduction inthe number of | The AimanfunLumea Comfort(Model: A-3588)is indicated forpatient removalof unwanted hairby using aselectivephotothermaltreatment underthe direction of aphysician, aftertraining by ahealthcare | The IPL HairRemoval Device(Model: UI04A,UI04B, UI04C) isindicated forpatient removalof unwanted hairby using aselectivephotothermaltreatment underthe direction of aphysician, aftertraining by a | Same |
| Elements ofcomparison | Subject Device1# K221214 | Subject Device2# K221214 | Subject Device3# K221214 | Predicate Device1# K160968 | Predicate Device2# K170269 | Predicate Device3# K212907 | Predicate Device4# K213558 | Remark |
| removal device isalso intended forpermanent reductionin unwanted hair.Permanent hairreduction is definedas the long-termstable reduction inthe number of hairsregrowing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen. | removal device isalso intended forpermanent reductionin unwanted hair.Permanent hairreduction is definedas the long-termstable reduction inthe number of hairsregrowing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen. | removal device isalso intended forpermanent reductionin unwanted hair.Permanent hairreduction is definedas the long-termstable reduction inthe number of hairsregrowing whenmeasured at 6. 9. and12 months after thecompletion of atreatment regimen. | defined as thelong-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatmentregime. | hairs regrowingwhen measured at6, 9, and 12months after thecompletion oftreatment regimen. | professional. TheAimanfun LumeaComfort is alsointended forpermanentreduction inunwanted hair.Permanent hairreduction isdefined as thelong-term stablereduction in thenumber of hairsregrowing whenmeasured at 6. 9.and 12 monthsafter thecompletion of atreatmentregimen | healthcareprofessional. TheIPL HairRemoval Deviceis also intendedfor permanentreduction inunwanted hair.Permanent hairreduction isdefined as thelong-term stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatmentregimen. | ||
| The device is usedfor adults withFitzpatrick skin typesI – IV. | The device is usedfor adults withFitzpatrick skin typesI – IV. | The device is usedfor adults withFitzpatrick skin typesI – IV. |
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Image /page/6/Picture/5 description: The image shows the Chinese characters "天之唯美" in black, with the English transliteration "TIANZHIWEIMEI" written below in a smaller font size. The characters are bold and have a simple, modern design. The overall impression is clean and professional.
Version:1.1
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Image /page/7/Picture/1 description: The image shows a logo with Chinese characters and the romanized version of the characters. The Chinese characters are "天之唯美", which are written in a bold, sans-serif font. Below the Chinese characters, the romanized version of the characters, "TIANZHIWEIMEI", is written in a smaller, sans-serif font. The logo is black and white.
Version:1.1
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Image /page/8/Picture/1 description: The image shows the text "TIANZHIWEIMEI" in all caps, with a larger font size for the Chinese characters above it. The Chinese characters are arranged horizontally, with each character being distinct and clear. The English text is smaller and placed directly below the Chinese characters, also arranged horizontally. The overall design is simple and clean, with a focus on readability.
Version:1.1
Comparison in Detail(s):
Note 1#,2#,3#,4#,5#:
Although it is a little different from the subject device,and is device,but they all comply with IEC 60601-2.83 requirement.So the differences of function specification will not raise any safety or effectiveness issue.
Note 6#
Although the subject device (model: F-608&FZ-608G) and The Aimantin Lumea Comfort (Model: A-3588) from K212907, provides an ice-sensing function, which utilizes a thermoelectric cooler under the skin contaction is only to make patients confortable with slightly cool sensation after IPL treatment, and have no
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Image /page/9/Picture/0 description: The image shows the Chinese characters "天之唯美" followed by the English transliteration "TIANZHIWEIMEI" in a simple, bold font. The Chinese characters are arranged horizontally above the English text. The text is black against a white background.
therapeutic effect. The difference does not result in a change of IPL technical specifications, so the affect the safety and effectiveness.
Conclusion
The subject device has similar features of the same intended use. Thus, the differences would not raise any problem in substantial equivalence claims,the subject device is the same or similar to the predicate device.
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Image /page/10/Picture/0 description: The image shows the text "天之唯美 TIANZHIWEIMEI" in a stylized font. The top line features four Chinese characters, while the bottom line spells out the romanized version of the Chinese characters. The text is black and is set against a white background. The font is bold and sans-serif.
7. PERFORMANCE DATA
The testing for Hand-held IPL device (IPL Hair Removal Device) included performance, software, electrical safety, EMC, biocompatibility and bench. Hand-held IPL device (IPL Hair Removal Device) passed all testing in support of the substantial equivalence determination:
7.1. Biocompatibility testing
The biocompatibility evaluation for the Hand-held IPL device (IPL Hair Removal Device) was conducted in accordance with
International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process." As dictated by the application and duration of contact with the intact skin, the enclosure of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
7.2. Electrical safety and electromagnetic compatibility
Electrical safety, performance and EMC testing were conducted on the Hand-held IPL device (IPL Hair Removal Device) . The device with compliance with the AAMI/ANSI ES60601-1, IEC 60601-2-83 and standards for safety and the IEC 60601-1-2 standard for EMC.
Software Verification and Validation Testing 7.3.
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 of concern.
Validation testing 7.4.
Bench Testing for the parameters of wavelength, pulse duration, output energy, and maximum fluence of each model at each treatment level. to verify that the proposed device met all design specifications as was the same or similar to the predicate device.
8. Conclusions:
The proposed device has the same intended use and similar technology characteristics as the predicate device, Ipulse Smoothskin Gold Hair Removal Device(K160968), Hee HR Mini (K170269),IPL Hair Removal Device (K213558),Aimanfun Lumea Comfort, A-3588(K212907). Meanwhile, performance testing, bench testing, and safety report documentation submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness. Based on performance testing, the proposed device is the same or similar 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.