(85 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware features and basic safety mechanisms like a skin sensor. There is no mention of any adaptive algorithms or learning capabilities.
Yes
The device is indicated for permanent reduction in hair regrowth, which is a physiological change for a therapeutic purpose.
No
The device is an IPL hair removal device, indicated for the removal and permanent reduction of unwanted hair. Its purpose is therapeutic/cosmetic, not diagnostic.
No
The device description clearly outlines physical hardware components such as an external power adapter, finger switch, flash window, and skin sensor, and the device utilizes Intense Pulsed Light (IPL) which is a hardware-based technology.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The definition of an IVD involves testing samples like blood, urine, or tissue outside of the body to provide information about a person's health.
- This device is used directly on the human body. The IPL Home Use Hair Removal Device applies light energy to the skin for hair removal. It does not involve collecting or analyzing any biological specimens.
- The intended use is for hair removal. The primary function is a cosmetic or aesthetic treatment, not a diagnostic test.
Therefore, this device falls under the category of a medical device that is applied to the body, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Home Use Hair Removal Device (Models:JD-TM003, JD-TM003, JD-TM012, JD-TM016, JD-TM022),is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
The subject device includes five models. The three models of JD-TM002,JD-TM003,JD-TM012 are white , JD-TM016 has two colors of white and purple while three colors of rose gold, green and champagne for JD-TM022. Except JD-TM022, the other four models have cooling function to relieve pain of burning sensation during operation. Except JD-TM002, you can use auxiliary head to limit the spot area and get better effect with the other four models. The auxiliary head is suitable for small parts such as underarms and lips.
IPL Home Use Hair Removal Device, models: JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, size, weight, energy density , number of levels and auxiliary head. The little difference won't affect the safety and effectiveness of the device.
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
Not Found
Intended User / Care Setting
over-the-counter, home-use and single-person-use device
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 following performance data were provided in support of the substantial equivalence determination.
- Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
- Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
IEC 60601-1-11 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 Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use.
- Eve Safetv
-
IEC 62471 Photobiological safety of lamps and lamp systems
-
Software Verification and Validation
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. -
Usability
The product usability has been evaluated and verified according to the following FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
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.
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.
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 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.
September 6, 2023
Foshan Jindi Electric Appliance Co.,Ltd % Yvonne Liu Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90, Qianhai Road Shenzhen, Guangdong 518052 China
Re: K231717
Trade/Device Name: IPL Home Use Hair Removal Device, Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 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: OHT Dated: June 12, 2023 Received: June 13, 2023
Dear Yvonne Liu:
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.
1
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.
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 (OS) 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.
Tanisha Hithe 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) /K231717
Device Name IPL Home Use Hair Removal Device Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022
Indications for Use (Describe)
IPL Home Use Hair Removal Device is indicated for the removal of unwanted harr. The device is also indicated for the permanent reduction in hair regrowth, 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K231717
"510(k) Summary" as required by 21 CFR Part 807.92.
I. Submitter
Foshan Jindi Electric Appliance Co.,Ltd
No.13 Baiye Avenue, Xiqiao Science and Technology Industrial Park, Xiqiao Town, Nanhai District, Foshan City, Guangdong Province, China Post code: 528211 Tel.: +86 18316578883 Zhaozhi Li Legal Person Tel: +86 18316578883 Email: renyigea@126.com
II. Device
Name of Device: IPL Home Use Hair Removal Device Model(s): JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 Common or Usual Name: Light Based Over-The-Counter Hair Removal Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHT Regulation Number: 21 CFR 878.4810
III. Predicate Device
Primary predicate device:
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| CyDen Limited. | iPulse Smoothskin Gold Hair | ||
| Removal System | K160968 | April 14, 2016 |
Secondary predicate device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Jizhimei | |||
| Technology Co., Ltd | IPL Cooling Hair Removal | ||
| Device (NBB01, NBB02) | K230360 | April 10, 2023 |
Reference device:
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Yangyi | |||
| Technology Co., Ltd | IPL Hair Removal Device, | ||
| Model(s): AP10,AP20,AP30,AP32 | K230021 | March 31, 2023 |
IV. Device Description
4
IPL Home Use Hair Removal Device (Models:JD-TM003, JD-TM003, JD-TM012, JD-TM016, JD-TM022),is an over-the-counter, home-use and single-person-use device for hair reduction by using Intense Pulsed Light (IPL). It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with minimal pain.
The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts irreplaceable flash window and is suitable for multiple hair removal areas (such as: lips, underarms, bikini lines, arms, legs, etc.). It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses.
The subject device includes five models. The three models of JD-TM002,JD-TM003,JD-TM012 are white , JD-TM016 has two colors of white and purple while three colors of rose gold, green and champagne for JD-TM022. Except JD-TM022, the other four models have cooling function to relieve pain of burning sensation during operation. Except JD-TM002, you can use auxiliary head to limit the spot area and get better effect with the other four models. The auxiliary head is suitable for small parts such as underarms and lips.
IPL Home Use Hair Removal Device, models: JD-TM002, JD-TM003, JD-TM012, JD-TM016, JD-TM022 have the same indication for use, performance, structure design and operation. The main difference mainly contains product appearance, size, weight, energy density , number of levels and auxiliary head. The little difference won't affect the safety and effectiveness of the device.
V. Indications for Use
IPL Home Use Hair Removal Device is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, 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.
VI. Materials
| Component
| name | Material of Component | Body Contact Category | Contact Duration |
|---|---|---|---|
| IPL Home Use | |||
| Hair Removal | |||
| Device | |||
| (Enclosure and | |||
| flash window) | ABS, PC | Surface-contacting | |
| device: Intact skin | Less than 24 hours |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section 16 "Biocompatibility Discussion".
VII. Comparison of Technological Characteristics With the Predicate Device
The IPL Home Use Hair Removal Device has the same intended use, mode of action and similar operational characteristics as the predicate devices. Any minor differences between the subject device and the listed predicate devices and reference device do no raise any issues of safety or efficacy. Performance
5
data supports that the device is safe and as effective as the predicate devices and reference device for its intended use. Therefore, the IPL Home Use Hair Removal Device may be found substantially equivalent to its predicate devices and reference device.
IPL Home Use Hair Removal Device is compared with the following Predicate Device and Reference Devices in terms of intended use, design, material,specifications, and performance:
| Comparison
Elements | Subject Device | Primary Predicate
Device | Secondary Predicate
Device | Reference Device | Remark |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------|
| 510(k) Number | Pending | K160968 | K230360 | K230021 | / |
| Trade name | IPL Home Use Hair
Removal Device (JD-
TM002,JD-TM003,JD-
TM012,JD-TM016,JD-
TM022) | iPulse Smoothskin Gold Hair Removal System | IPL Cooling Hair
Removal Device
( NBB01, NBB02 ) | IPL Hair Removal
Device,
Model(s):AP10,AP20
,AP30,AP32 | / |
| Manufacturer | Foshan Jindi Electric
Appliance Co.,Ltd | CyDen Limited. | Shenzhen
Jizhimei
Technology Co.,Ltd | Shenzhen
Yangyi
Technology Co.,Ltd | |
| Regulation
number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT, GEX | OHT | OHT | Same |
| Device
classification | Class II | Class II | Class II | Class II | Same |
| Indication
for
use/
Intended
use | IPL Home Use Hair
Removal Device is
indicated for the
removal of unwanted
hair. The device is also
indicated for the
permanent reduction in
hair regrowth, 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. | 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,
defined as the long-
term, stable
reduction in the
number of hairs
regrowing when
measured at 6, 9 and
12 months after the | The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and /or facial hair. | IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and /or facial hair. | Same |
| | | completion
of a
treatment regime. | | | |
| Prescription or
OTC | OTC | OTC | OTC | OTC | Same |
| Device design | | | | | |
| Source energy | Supplied by external
adapter | Supplied by external
adapter | Supplied by external
adapter | Supplied by external
adapter | Same |
| Power Supply | 100-240V~, 50/60Hz | 110V or 230V,
50/60Hz | 100-240V, 50/60Hz | 100-240V AC | Same |
| Dimension | JD-TM002:
1387847mm
JD-TM003:
1457550mm
JD-TM012:
1957347mm
JD-TM016:
18010047mm
JD-TM022:
17614791mm | Unknown | NBB01:
47.654.3240mm
NBB02-MAX:
2357643mm | AP10:
20118480mm
AP20:
20916178mm
AP30:
1666240mm
AP32: 1676341mm | Different
Note 1 |
| Sterilization | Not required | Not required | No | Not required | Same |
| Output specification | | | | | |
| Light Source | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Intense Pulsed Light | Same |
| Energy
medium | Xenon Arc Flashlamp | Xenon Arc
Flashlamp | Xenon Arc Flashlamp | Xenon Arc Flashlamp | Same |
| Wavelength
range | JD-TM002,JD-TM003:
550-1100nm
JD-TM012,JD-TM016:
600-1100nm
JD-TM022:
640-1100nm | 510-1100nm | 550-1200mm | 530-1100nm | Same |
| Spot Size
( cm2 ) | JD-TM002,JD-
TM003,JD-TM012:
3 cm2
JD-TM016:
3.3 cm2
JD-TM022: 4 cm2 | 3cm2 | 3.6cm2 | 3.3cm2
3.96cm2 ,3.63cm2 | Similar
Note 2 |
| Energy
Density | JD-TM002,JD-
TM003,JD-TM012,
JD-TM016: $2-5 J/cm^2$
JD-TM022:
$2-6 J/cm^2$ | $3-6 J/cm^2$ | $2-5 J/cm^2$ (applicable
for model NBB01)
$2-4 J/cm^2$ (applicable
for model NBB02) | Max $4.3 J/cm^2$ | Similar
Note 3 |
| Pulse duration | 8-12ms | 2-10 ms | 6.4-7.2ms | 8.8-13.2 ms | Similar
Note 4 |
| Pulsing control | Finger switch | Finger switch | Finger switch | Finger switch | Same |
| Output
intensity level | JD-TM002,JD-
TM003,JD-TM012:
5 Levels
JD-TM016: 9 Levels
JD-TM022: 10 Levels | Unknown | NB001: 5 Levels
NBB02: 6 Levels | 5 (applicable for
model AP10,
AP30,AP32)
9 (applicable for
model AP20) | Similar
Note 3 |
| Delivery
Device | Direct Illumination to
Tissue | Direct Illumination
to Tissue | Direct Illumination to
Tissue | Direct Illumination to
Tissue | Same |
| Software/
Firmware/
Microprocesso
r Control? | Yes | Yes | Yes | Yes | Same |
| Additional features | | | | | |
| Electrical
safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | IEC 60601-1
IEC 60601-1-2 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | Similar |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibili
ty | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10
ISO 10993-12 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
6
7
Note 1:
Though the dimensions are different from the predicate device, this difference is insignificant and do not raise any safety/ effectiveness problems.
Note 2:
There is minor difference in spot size between the subject device and the predicate devices and reference device. The spot size is related to light intensity and since the difference in light intensity is not significant as explained in note 3, so this difference will not raise any safety or effectiveness issue.
8
Note 3:
Though the energy density and output intensity level are a little different from the predicate devices and reference device, the energy density of subject device is within the range of the minimum and maximum value of the predicate devices and reference device, and they all comply with IEC 60601-2-57 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Note 4:
Though the pulse duration of subject device is a little different from the predicate devices and reference device, and the subject device complies with IEC 60601-2-57 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
VIII. Performance Data
The following performance data were provided in support of the substantial equivalence determination.
1) Biocompatibility Testing
The biocompatibility evaluation for the body-contacting components of the IPL Home Use Hair Removal Device was conducted in accordance with the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including:
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices -Par t 5: Tests for In Vitro Cytotoxicity
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices –Par t 10: Tests for Irritation and Skin Sensitization
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, as per the following standards:
-
IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility
-
ANSI AAMI ES60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
-
IEC 60601-1-11 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 Medical electrical equipment Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic,monitoring and cosmetic/aesthetic use.
3) Eve Safetv
-
IEC 62471 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
9
Software documentation consistent with moderate level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.
5) Usability
The product usability has been evaluated and verified according to the following FDA guidance > Applying Human Factors and Usability Engineering to Medical Devices, issued on FEBRUARY 2016
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device IPL Home Use Hair Removal Device is as safe, as effective, and performs as well as the legally marketed predicate device and reference devices.