(55 days)
No
The description focuses on the IPL technology, skin sensor, and cooling function. There is no mention of AI, ML, or any learning or adaptive capabilities. The software validation is standard for medical devices and does not indicate AI/ML.
No.
The device is intended for cosmetic hair removal and not for treating a disease, injury, or medical condition.
No
The device is intended for hair removal, a cosmetic function, and does not diagnose any medical conditions or provide information for diagnosis.
No
The device description clearly outlines hardware components such as an external power adapter, finger switch, light exit, skin sensor, and cooling function. It also mentions electrical safety and EMC testing, which are related to hardware performance. While software verification and validation are mentioned, the device itself is a physical device utilizing Intense Pulsed Light technology, not solely software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The IPL Hair Removal Device uses light energy applied externally to the skin to reduce hair growth. It does not analyze any biological samples taken from the body.
- Intended Use: The intended use is for the removal of unwanted body and or facial hair, which is a cosmetic or aesthetic purpose, not a diagnostic one.
The description clearly indicates it's a device that interacts with the external surface of the body using light, not a device that analyzes internal biological samples.
N/A
Intended Use / Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
Product codes (comma separated list FDA assigned to the subject device)
OHT
Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. The device 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.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.
The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intense Pulsed Light
Anatomical Site
Body and/or facial hair (e.g., face, lips, underarms, bikini lines, arms, legs)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over-the-counter, home-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 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 passed, including:
- ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
- ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
- Electrical Safety and EMC: Electrical safety and EMC testing was performed to, and passed, the following standards:
- ANSI AAMI ES60601-1 Medical electrical equipments for basic safety and essential performance
- IEC 60601-1-2 Medical electrical equipment Pat 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests
- 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 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
- Eye Safety:
- 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.
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.
K230097, K230739, K230060, K220222
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 & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2023
Shenzhen Lescolton Electrical Appliance Co., Ltd. % Gong Youshan RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Oianhai Road Shenzhen, Guangdong 518052 China
Re: K232499
Trade/Device Name: IPL Hair Removal Device (LS-T106, LS-T107, LS-T108) 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: August 16, 2023 Received: August 17, 2023
Dear Gong Youshan:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Digitally signed by Jianting Jianting Wang -S Wang -S Date: 2023.10.11 12:08:29 -04'00'
For Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices
2
Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232499
Device Name IPL Hair Removal Device
Indications for Use (Describe)
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and or facial hair.
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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4
K232499 510(k) Summary
"510(k) Summary" as required by 21 CFR Part 807.92.
Date Prepared: 2023-09-29
I. Submitter
Shenzhen Lescolton Electrical Appliance Co., Ltd.
Room 301, Building 04, No. A3, Fourth Industrial Zone, Heshuikou Community, Matian Street, Guangdong, China
Post code: 518105 Tel.: 400 153 8008
Qixiang Liu Management representative Tel: +86 13530009850 Email: info@lescolton.com
II. Device
Name of Device: IPL Hair Removal Device Model(s): LS-T106, LS-T107,LS-T108 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 and Reference Device
- A Predicate Device
5
| Manufacturer | Predicate Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| Jizhimei | |||
| Technology Co., Ltd. | IPL Cooling Hair Removal | ||
| Device, Model(s): NBB01, | |||
| NBB02 | K230360 | April 10, 2023 |
Reference Device1 A
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| Technology | |||
| Electronics Co., Ltd. | BSX IPL Hair Removal Device, | ||
| Model(s): BSXT101, | |||
| BSXT102, BSXT103, | |||
| BSXT105, BSXT106, | |||
| BSXT108 | K230097 | April 6, 2023 |
Reference Device2 A
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen | |||
| IONKA | |||
| Medical Technology | |||
| Co., Ltd. | Hand-held IPL device (IPL | ||
| Home Use Hair Removal | |||
| Device), Model: FZ-608, | |||
| FZ-608G, FZ-100, FZ-200 | K230739 | May 26, 2023 |
A Reference Device3
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen GSD Tech | |||
| Co., Ltd. | Light Based Hair Removal | ||
| Device GP592 | K230060 | March 3, 2023 |
6
A Reference Device4
| Manufacturer | Reference Device | 510(k) Number | Approval Date |
|---|---|---|---|
| Shenzhen Yuwei | |||
| Electronic Technology | |||
| Co., Ltd. | IPL Hair Removal Device | K220222 | April 26, 2022 |
IV. Device Description
IPL Hair Removal Device, is an over-the-counter, home-use device for unwanted hair reduction by using Intense Pulsed Light (IPL), and it has been designed three models with the same IPL technology for hair removal, which is model LS-T107 and LS-T108. The device 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.
The IPL Hair Removal Device has an irreplaceable light exit and it can cover an area of 3.2cm2 of LS-T106 and LS-T108, 3.7cm2 of LS-T107 that is suitable for multiple hair removal areas, such as face, lips, underarms, bikini lines, arms, legs, etc.
The device contains a skin sensor to detect appropriate skin contact, if the light exti is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the IPL Hair Removal Device has the cooling function, which will be activated throughout the whole har removal process to cool down the treatment area' s temperature and provide the user with a better using experience.
V. Indications for Use
The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair.
VI. Materials
| Model | Contacted Component Name | Materials |
|---|---|---|
| ------- | -------------------------- | ----------- |
7
| LS-T106, LS-T107 | Host of machine (including air outlet, treatment
window, air inlet, buttons) | PC+ABS |
|------------------|---------------------------------------------------------------------------------|--------|
| LS-T108 | Host of machine (including air outlet, treatment
window, air inlet, buttons) | PC+ABS |
| | Sapphire cold head (within treatment window) | AL2O3 |
We have tested the device for biocompatibility by a reliable third-party lab. For details, please refer to Section "013 Biocompatibility evaluation report of IPL Hair Removal Device"
VII. Comparison of Technological Characteristics With the Predicate Device
The IPL Hair Removal Device has the same intented use as the predicate. The technological characteristics such as wavelength, energy density, spot size and pulse duration, are similar to the predicate devices. Any minor differences between the subject device and the listed predicate device and reference devices of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate device and reference devices for its intended use.
Therefore, the IPL Hair Removal Device may be found substantially equivalent to its predicate devices.
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K232499 | K230360 | K230097 | K230739 | K230060 | K220222 | / |
| Trade name | IPL Hair Removal Device | IPL Cooling Hair
Removal Device | IPL Hair
Removal Device | Hand-held device (IPL Home
Use Hair Removal Device) | IPL Light Based
Hair Removal Device GP592 | IPL Hair
Removal Device | / |
| Manufacturer | Shenzhen Lescolton
Electrical Appliance Co., Ltd | Shenzhen Jizhimei
Technology Co.,
Ltd. | Shenzhen BSX
Technology
Electronics Co., | Shenzhen IONKA
Medical Technology
Co., Ltd. | Shenzhen GSD
Tech Co., Ltd. | Shenzhen Yuwei
Electronic | / |
| Comparison Elements | Subject Device | Predicate Device | Reference Device 1 | Reference Device 2 | Reference Device 3 | Reference Device 4 | Remark |
| | | | Ltd. | | | Technology Co., Ltd. | |
| Regulation number | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | 21 CFR 878.4810 | Same |
| Product code | OHT | OHT | OHT | OHT | OHT | OHT | Same |
| Device classification | Class II | Class II | Class II | Class II | Class II | Class II | Same |
| Indication for use/ Intended use | The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. | The IPL Cooling Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/or facial hair. | The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body and/ or facial hair. | 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. | Light based hair removal device is an over-the-counter device intended for removal of unwanted hair such as but not limited to small areas such as underarm and facial hair below the chin line and large areas such as legs, excluding patients with Fitzpatrick Skin Phototypes VI. | The IPL Hair Removal Device is an over-the-counter device intended for removal of unwanted body hair. | Same |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
| Prescription or OTC | OTC | OTC | OTC | OTC | OTC | OTC | Same |
| Applicable skin | Fitzpatrick skin types I-V | Fitzpatrick
skin
types I-V | Fitzpatrick Skin
Types I-V | Fitzpatrick
Skin
Types I-V | Fitzpatrick
Skin Types I-
V | Not publicly
available | Same |
| Dimension | LS-T106:
$202.3\pm0.83856.2$ mm
LS-T107: $211.563.548.9$
mm
LS-T108: $177.56740$ mm | NBB01:
$47.654.3240$ mm
NBB02-MAX:
$2357643$ mm | $190 x 70 x 45$
mm | FZ-608, FZ-608G:
$9814760$ (mm)
FZ-100:
$1987144$ (mm)
FZ-200:
$2166852$ (mm) | Not publicly
available | Not publicly
available | Different
Note 1 |
| Light source | Intense Pulsed Light | Intense
Pulsed
Light | Intense
Pulsed
Light | Intense Pulsed Light | Intense Pulsed
Light | Intense Pulsed
Light | Same |
| Energy medium | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc lamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Xenon Arc
Flashlamp | Same |
| Wavelength range | LS-T106: 610-1200nm
LS-T107: 560-1200nm
LS-T108: 470-1200nm | 550-1200mm | 470nm-1200nm | 510nm1200nm | Not5J/cm²
publicly
available | 610-1100nm | Similar,
the
wavelength
range of LS-
T106 is within
reference
device 1, and
the
minimum
wavelength
(610nm) of
LS-T106 is
identical to
reference
device 4.
Note 2 |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
| Energy density | LS-T106: 2.0-4.87J/cm²
LS-T107: 2.16-5.18J/cm²
LS-T108: 2.0-5.62J/cm² | 2
(applicable
for
model NBB01)
24J/cm²5.6 J/cm² | Similar, the
(applicable
for
model NBB02) | Max 5.0 J/cm² | FZ-608, FZ-608G:
3.33 J/cm2
FZ-100: 5.43 J/cm2
FZ-200: 4.5 J/cm2 | 4.93J/cm2
Max | 2.2
energy density
of LS-T106 is
within
predicate
device
of
model NBB01
and the min
energy density
of LS-T106 is
similar
to
reference
device 4, the
max energy
density of LS-
T106 is within
reference
device 4.
Note 3 |
| Output energy | LS-T106: 8/10/13J (±20%)
LS-T107: 10/13/16J (±20%)
LS-T108: 8/12/15J (±20%) | Model NBB01:
8 ~ 17.05J
Model NBB02:
7.14 ~ 13.62J | Pure mode:
510J (±20%)10J (±20%)
Armpit mode:
6
Body mode:
6.511J (±20%)12.5J (±20%) | FZ-608, FZ-608G:
Bikini mode:
8
Level 1: 4.16J
Level 2: 4.36J
Level 3: 5.1J
Level 4: 6.1J
Level 5: 6.96J
Level 6: 7.96J
Level 7: 8.63J
Level 8: 9.13J | Not publicly
available | Level 1: 8.82J
(±20%)
Level 2:
10.09J (±20%)
Level 3:
12.73J (±20%)
Level 4:
14.24J (±20%) | Similar,
consider the
error ± 20%,
the min output
energy of LS-
T106 is 6.4J which
is within
reference |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
| | | | | Level 9: 10.0J | | Level 5:
16.76J
(±20%) | device 1 on
armpit mode;
the max output
energy of LS-
T106 is 15.6J
which is
within
predicate
device on
model NBB01.
Also, the
output energy
is within
reference
device 4.
Note 3 |
| Spot size | LS-T106: 3.2 cm²
LS-T107: 3.7 cm²
LS-T108: 3.2 cm² | 3.6cm² (applicable
for model NBB01
and NBB02) | 3.0cm²± 0.5cm² | 3.0cm² | 1.05cm*2.95cm
(3.1cm²) | 3.0cm², 4.1cm² | Similar, the
spot size of
LS-T106 is
similar to
reference
device 1, 2, 3
and 4.
Note 4 |
| Pulse duration | LS-T106: 0.64-2.4ms
LS-T107: 7.2-10.8ms
LS-T108: 6.8-10.2ms | 6.4-7.2ms | 4-10ms | 0.50.8 ms | 13 ms | 814ms | Similar, the5 levels | Different
min pulse
duration of
LS-T106 is |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
| | | | | | | | 0.64ms which
is within
reference
device 2, the
max pulse
duration of
LS-T106 is
2.4ms which is
within
reference
device 3.
Note 5 |
| Output intensity level | LS-T106: 3 levels
LS-T107: 3 levels
LS-T108: 3 levels | NBB01: 5 levels
NBB02: 6 levels | 5 Levels | FZ-608, FZ-608G: 9
levels
FZ-100: 9 levels
FZ-200: 6 levels | Not publicly
available | 1
Note 6 |
| Software/
Firmware/
Microprocessor Control? | Yes | Yes | Yes | Yes | Yes | Yes | Same |
| Electrical safety | 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 | ANSI AAMI
ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | AAMI
ANSI
ES60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | ANSI AAMI
ES60601-1
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-
57 | Same |
| Eye safety | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | IEC 62471 | Same |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | Same |
| Comparison Elements | Subject Device | Predicate Device | Reference
Device 1 | Reference Device 2 | Reference
Device 3 | Reference
Device 4 | Remark |
| | | | | | ISO 10993-23 | | |
8
9
10
11
12
13
Note 1:
Though the dimension is different from the predicate device, this difference is insignificant and do not raise any safety or effectiveness problems.
Note 2:
Though the wavelength of subject device is different from the predicate device, the wavelength of the subject device can be basically covered by the reference device 1's range. The wavelength range of LS-T106 is within reference device 1, and the min wavelength (610mm) of LS-T106 is identical to reference device 4, and they all comply with IEC 60471 requirements, so this difference will not raise any safety or effectiveness issue.
Note 3:
Though the energy density and the output energy of subject device is a little different from the predicate device and reference devices, consider the error ±20%, the energy density and the output device is within the range of the minimum and maximum value of the predicate device and reference devices.
The energy density of LS-T106 is within predicate device of model NBB01, and the min energy density of LS-T106 is similar to reference device 4. the max energy density of LS-T106 is within reference device 4.
The min output energy of LS-T106 is 6.41 which is within reference device 1 of armpit mode; the max output energy of LS-T106 is 1.5.61 which is within predicate device of model NBB01. Also, the output energy is within reference device 4, and they all comply with IEC 60601-2-83 and IEC 62471 requirements, so this difference will not raise any safety or effectiveness issue.
Note 4:
There is minor difference in spot size between the reference devices. The spot size is related to energy density while the energy density of subject device and predicate device is the same as explained in Note 3, the spot size of LS-T106 is similar to reference device 1, 2, 3 and 4, so this difference is not significant and will not raise any safety or effectiveness issue.
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Note 5:
Though the pulse duration of subject device is different from the predicate device, the range of LS-T107, LS-T108 is within reference device 1. The min pulse duration of LS-T106 is 0.64ms which is within reference device 2, the max pulse duration of LS-T106 is 2.4ms which is within reference device3. In addition, the subject device comply with IEC 60471 requirement, so this difference will not raise any safety or effectiveness issue.
Note 6:
Though the output intensity level of subject device is different from the predicate device and reference devices, the wavelength, output energy and energy density of the subject device can be basically same with predicate devices as explained in Note 3, and they all comply with IEC 60601-2-83 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 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 passed,
including:
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ISO 10993-5:2009, Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
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ISO 10993-10:2021, Biological evaluation of medical devices -Part 10: Tests for skin sensitization
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ISO 10993-23:2021, Biological evaluation of medical devices -Part 23: Tests for skin irritation
2) Electrical Safety and EMC
Electrical safety and EMC testing was performed to, and passed, the following standards:
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ANSI AAMI ES60601-1 Medical electrical equipments for basic safety and essential performance
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IEC 60601-1-2 Medical electrical equipment Pat 1-2: General requirements for basic safety and essential performance Collateral Standard: Electromagnetic disturbances - Requirements and tests
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-
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
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IEC 60601-2-83 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
3) Eye Safety
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IEC 62471 Photobiological safety of lamps and lamp systems
4) 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.
IX. Conclusions
Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate device and reference device.