(147 days)
Not Found
No
The summary describes a standard IPL device with a skin proximity sensor and does not mention any AI/ML capabilities or related software features.
Yes.
The 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." This describes a medical treatment for a condition (unwanted hair) performed on a patient. It also mentions "permanent reduction in unwanted hair," which implies a lasting therapeutic effect.
No.
The device's stated intended use is for hair removal, which is a treatment, not a diagnostic purpose. There is no information suggesting it analyzes or identifies medical conditions.
No
The device description clearly outlines hardware components such as a hand-held applicator, external power supply, lamp, and skin proximity sensor. The summary also mentions electrical safety and bench testing, which are associated with hardware devices.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "patient removal of unwanted hair by using a selective photothermal treatment". This is a therapeutic or cosmetic application, not a diagnostic one.
- Mechanism of Action: The device uses "selective photosynthesis in which optical energy is used to disable hair growth". This is a physical interaction with the body, not an in vitro test of a sample.
- No mention of testing samples: IVD devices are designed to test samples (like blood, urine, tissue) outside of the body to diagnose or monitor a condition. This device interacts directly with the skin.
Therefore, this device falls under the category of a therapeutic or cosmetic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ONF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
under the direction of a physician, after training by a healthcare professional.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
7.3. Software Verification and Validation Testing
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.
7.4. Validation testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K160968, K170269, K213558, K212907
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
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
1
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
2
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,Xixiang |
| street,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 Inspiration |
| Limited | ||
| 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 of
comparison | Subject Device
1# K221214 | Subject Device
2# K221214 | Subject Device
3# K221214 | Predicate Device
1# K160968 | Predicate Device
2# K170269 | Predicate Device
3# K212907 | Predicate Device
4# K213558 | Remark |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Device
Name and
Model | IPL home use hair
removal device
FZ-608&FZ-608G | IPL home use hair
removal device
FZ-100 | IPL home use hair
removal device
FZ-200 | Ipulse
Smoothskin
Gold Hair
Removal Device | Hee HR Mini | Aimanfun Lumea
Comfort, A-3588 | IPL Hair
Removal Device | / |
| Manufacturer | Shenzhen IONKA
Medical Technology
Co., Ltd. | Shenzhen IONKA
Medical Technology
Co., Ltd. | Shenzhen IONKA
Medical Technology
Co., Ltd. | Cyden Limited | Oriental
Inspiration
Limited | Kam Yuen
Plastic Products
Ltd | Ulike Co., Ltd | / |
| Classification
n Product
Code | ONF | ONF | ONF | OHT, GEX | OHT | ONF | ONF | Same |
| Light source | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | 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 |
| Energy
output | Level 2: 4.36J
Level 3: 5.1J | Level 2: 6.5J
Level 3: 8.06J | Level 2: 5.7J
Level 3: 6.63J | 9 - 18 J | 15 J max | 7 - 13.5 J | 7 – 20 J | |
| Elements of
comparison | Subject Device
1# K221214 | Subject Device
2# K221214 | Subject Device
3# K221214 | Predicate Device
1# K160968 | Predicate Device
2# K170269 | Predicate Device
3# K212907 | Predicate Device
4# K213558 | Remark |
| | Level 4: 6.1J
Level 5: 6.96J
Level 6: 7.96J
Level 7: 8.63J
Level 8: 9.13J
Level 9: 10J | Level 4: 9.73J
Level 5: 11.96J
Level 6: 14.1J
Level 7: 15.13J
Level 8: 15.33J
Level 9: 16.26J | Level 4: 8.66J
Level 5: 11.3J
Level 6: 13.5J | | | | | Note 3# |
| Energy
density 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 | $2.3 - 4.5 J/cm^2$ | $2.1 - 6 J/cm^2$ | Similar
Note 4# |
| Pulse
duration | 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 | similar
Note 5# |
| Skin contact
sensor | Yes | Yes | Yes | Yes | Yes | Yes | Yes | same |
| Cooling
system | Yes (thermoelectric
cooler) | Yes (thermoelectric
cooler) | Yes (semiconductor
refrigeration sheet) | No | No | Yes
(thermoelectric
cooler) | No | same |
| Treatment
schedule | 1 X/week for 12
weeks | 1 X/week for 12
weeks | 1 X/week for 12
weeks | 1 X/week for 12
weeks | 1X every 2 weeks
for 4 treatments,
1X every 4 weeks
for treatments 5-7,
then as needed | 1 X/week for 12
weeks | 1 X/week for 12
weeks | Same |
| Use
classification | Rx | Rx | Rx | OTC | OTC | Rx | Rx | Same |
| Ice-sensing
function | Yes | Yes | No | No | No | Yes | No | Same as
K212907
Note 6# |
| Elements of
comparison | Subject Device
1# K221214 | Subject Device
2# K221214 | Subject Device
3# K221214 | Predicate Device
1# K160968 | Predicate Device
2# K170269 | Predicate Device
3# K212907 | Predicate Device
4# K213558 | Remark |
| Delivery
Device | Direct Illumination to
Tissue | Direct Illumination to
Tissue | Direct Illumination to
Tissue | Direct
Illumination to
Tissue | Direct
Illumination to
Tissue | Direct
Illumination to
Tissue | Direct
Illumination to
Tissue | same |
| Pulsing
Control | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | Finger switch | same |
| Skin Tone
Sensor | Optical Measurement
Integral to device.
Continuous
measurement. | Optical Measurement
Integral to device.
Continuous
measurement. | Optical Measurement
Integral to device.
Continuous
measurement. | Optical
Measurement
Integral to
device.
Continuous
measurement. | Optical
Measurement
Integral to device.
Continuous
measurement. | Optical
Measurement
Integral to
device.
Continuous
measurement. | Optical
Measurement
Integral to device.
Continuous
measurement. | same |
| Specific
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 | 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 | 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 | The iPulse
SmoothSkin
Gold Hair
Removal System
is indicated for
the removal of
unwanted hair.
The iPulse
SmoothSkin
Gold is also
indicated for the
permanent
reduction in hair
regrowth | HEE HR Mini is
an over-the-
counter device
intended for the
removal of
unwanted hair.
The HEE HR Mini
is also intended for
permanent
reduction in hair
regrowth, defined
as a long-term,
stable reduction in
the number of | The Aimanfun
Lumea Comfort
(Model: A-3588)
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 | The IPL Hair
Removal Device
(Model: UI04A,
UI04B, UI04C) is
indicated for
patient removal
of unwanted hair
by using a
selective
photothermal
treatment under
the direction of a
physician, after
training by a | Same |
| Elements of
comparison | Subject Device
1# K221214 | Subject Device
2# K221214 | Subject Device
3# K221214 | Predicate Device
1# K160968 | Predicate Device
2# K170269 | Predicate Device
3# K212907 | Predicate Device
4# K213558 | Remark |
| | 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. | 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. | 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. | 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
regime. | hairs regrowing
when measured at
6, 9, and 12
months after the
completion of
treatment regimen. | 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 | healthcare
professional. The
IPL 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 device is used
for adults with
Fitzpatrick skin types
I – IV. | The device is used
for adults with
Fitzpatrick skin types
I – 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
8
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.