(134 days)
None
No
The description focuses on the laser technology, skin contact sensor, and cooling feature. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is intended for hair removal and permanent hair reduction, which are considered medical purposes, as it alters the structure and function of the body (hair follicles).
No
The device is described as a hair removal device, intended for permanent hair reduction, which is a therapeutic rather than a diagnostic function.
No
The device description clearly outlines hardware components such as a laser emitter, sensor, skin cooling feature, and external power adaptor. The performance studies also include testing related to hardware (biocompatibility, electrical safety, shelf life, cleaning/disinfection).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for hair removal and permanent hair reduction, which is a physical treatment applied to the body.
- Device Description: The device uses a laser to target hair follicles within the skin. This is a direct interaction with the body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. This device does not perform any such tests on samples.
The device described is a therapeutic device that interacts directly with the patient's body for a cosmetic/medical procedure.
N/A
Intended Use / Indications for Use
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.
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 regime. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
Product codes
GEX
Device Description
The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
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
Not Found
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
No clinical testing has been performed.
Non-Clinical Tests:
- Biocompatibility Testing: According to ISO 10993-1:2018, performed in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021 for parts contacting intact skin.
- Electrical Safety and Electromagnetic Compatibility Testing: Complied with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1.
- Software Verification and Validation: Performed according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Performance Test (Bench): Appearance, Function, Safety, Label.
- Shelf Life Test: Accelerated aging test and performance test after accelerated aging.
- Cleaning and Disinfection Verification: Simulated cleaning and disinfection test and performance test after simulated cleaning and disinfection.
Key Results: All bench test results are provided in the Performance Test Report, demonstrating that the device is as safe, effective, and performs as well as or better than the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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). 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.
November 28, 2023
Wuhan Lotuxs Technology Co., Ltd. Na Wu Quality Manager 501/E2, No.999 High-tech Avenue Wuhan, Hubei 430206 China
Re: K232117
Trade/Device Name: Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) 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: GEX Dated: November 24, 2023 Received: November 24, 2023
Dear Na Wu:
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.
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).
1
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,
Image /page/1/Picture/7 description: The image shows a digital signature. The signature is for "Jianting Wang -S". The date of the signature is "2023.11.28" and the time is "09:42:19-05'00'".
Date: 2023.11.28 09:42:19 -05'00' For Tanisha Hithe Assistant Director
DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
Submission Number (if known)
Device Name
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
Indications for Use (Describe)
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.
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 regime. Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
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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3
K232117
Wuhan Lotuxs Technology Co., Ltd.
Section 4 - 510(k) Summary Date of Summary Preparation: July 14, 2023
Date of Summary Modification: November 24, 2023
1. Submitter's Identifications
Submitter's Name: Wuhan Lotuxs Technology Co., Ltd. Address: 501/E2, No.999 High-tech Avenue, Wuhan 430206, China Contact Person: Na Wu Contact Title: Quality Manager Contact Email Address: na.wu@lotuxs.com Telephone: +86-27-87619668
2. Correspondent's Identifications
Correspondent's Name: Wuhan Lotuxs Technology Co., Ltd. Address: 501/E2, No.999 High-tech Avenue, Wuhan 430206, China ZIP Code: 430206 Contact Person: Na Wu Contact Title: Quality Manager Contact E-mail Address: na.wu@lotuxs.com Telephone: +86-27-87619668
3. Name of the Device
Device Classification Name: Powered laser surgical instrument Product Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Trade Name: Diode Laser Hair Removal Model: LHR-V6S-1064, LHR-V6S/B-1064 Classification Panel: General & Plastic Surgery Product Code: GEX Regulation Number: 21 CFR 878.4810 Device Classification: Class II
4. The Predicate Devices
Primary predicate device: K133319 ET LightSheer 1060 and High Speed LightSheer 1060 Secondary predicate device: K141425 Cynosure Elite+ Laser
5. Device Description
The Diode Laser Hair Removal device models LHR-V6S-1064 and LHR-V6S/B-1064 emit pulses of invisible infrared laser light of 1064nm wavelength that penetrates into the skin and is selectively absorbed by melanin in the hair follicles. This creates a localized thermal effect that disrupts hair growth from the hair follicles. The device contains a sensor that detects contact with the skin so that the device will only emit the infrared laser pulses when the sensor is in contact with the skin. The device also includes a skin cooling feature and the device is powered by an external AC/DC power adaptor.
6. Intended Use of Device
4
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for hair removal, permanent hair reduction.
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 regime.
Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.
7. Summary of Substantial Equivalence
| | Proposed device | Primary
predicate device | Secondary
predicate device | Comparison |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510k
Number | K232117 | K133319 | K141425 | — |
| Product
Code | GEX | GEX | GEX | — |
| Proprietary
Name | Diode Laser Hair
Removal | ET LightSheer
1060 and High
Speed
LightSheer 1060 | Cynosure Elite+
Laser | — |
| Model | LHR-V6S-1064,
LHR-V6S/B-1064 | / | / | — |
| Manufacture | Wuhan Lotuxs
Technology Co.,
Ltd. | Lumenis Ltd. | Cynosure LLC | — |
| Indications
for use | Diode Laser Hair
Removal
(LHR-V6S-1064,
LHR-V6S/B-1064)
is intended for hair
removal,
permanent hair
reduction.
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 regime.
Diode Laser Hair
Removal
(LHR-V6S-1064,
LHR-V6S/B-1064) | ET LightSheer
1060 and High
Speed
LightSheer 1060
are intended for
treatment of
vascular lesions,
including
angiomas,
hemangiomas,
telangiectasia,
port wine stains,
leg veins and
other benign
vascular lesions.
ET LightSheer
1060 and High
Speed
LightSheer 1060
are intended for
hair removal,
permanent hair
reduction, and
the treatment for | 1064 nm:
The Cynosure
Elite+ Laser is
intended for the
coagulation and
hemostasis of
benign vascular
lesions such as,
but not limited
to, port wine
stains,
hemangiomas,
warts,
telangiectasia,
rosacea, venus
lake, leg veins,
spider veins and
poikiloderma of
civatte; and
treatment of
benign
cutaneous
lesions such as
warts, scars | Same |
Table 1
5
| is intended for use
on all skin types
(Fitzpatrick skin
types I - VI),
including tanned
skin. | Pseudofolliculitis
Barbae (PFB3).
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
regime.
ET LightSheer
1060 and High
Speed
LightSheer 1060
are intended for
the treatment of
benign
pigmented
lesions,
including age
spots, solar
lentigines,
eaf6-au-lait
spots, nevi of
Otallto,
melasma,
Becker's nevi
and other benign
pigmented
lesions.
ET LightSheer
1060 and High
Speed
LightSheer 1060
are also intended
for treatment of
wrinkles.
ET LightSheer
1060 and High
Speed
LightSheer 1060
are intended for
use on all skin
types
(Fitzpatrick skin | striae and
psoriasis. The
laser is also
intended for the
treatment of
benign
pigmented
lesions such as,
but not limited
to, lentigos (age
spots), solar
lentigos (sun
spots), cafe au
lait macules,
seborrheic
keratoses, nevi,
chloasma,
verrucae, skin
tags, keratosis
and plaques.
The laser is also
indicated for the
treatment of
wrinkles such as,
but not limited
to, periocular
and perioral
wrinkles.
Additionally, the
laser is indicated
for the treatment
of
pseudofolliculitis
barbae (PFB)
and for stable
long-term, or
permanent hair
reduction.
Permanent hair
reduction is
defined as
long-term stable
reduction in the
number of hairs
regrowing when
measured at 6, 9
and 12 months
after the
completion of a
treatment |
|--------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
Wuhan Lotuxs Technology Co., Ltd.
6
| | | types I - VI),
including tanned
skin. | regime. | |
|---------------------------------------------------|----------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|----------|
| Laser Type | Solid state | Solid state | Solid state | Same |
| Wavelength | 1064nm±10nm | 1060nm | 1064nm±10nm | Same |
| Treatment
Activation | Fingerswitch | Footswitch or
Fingerswitch | Footswitch or
Fingerswitch | Same |
| Rx/OTC | Prescription | Prescription | Prescription | Same |
| Pulse Width | LHR-V6S-1064:
350ms-450ms
LHR-V6S/B-1064:
280ms-400ms | ET LightSheer
1060 handpiece:
5-400ms
High Speed
LightSheer 1060
handpiece:
30-400ms | 0.1ms-300ms | Similar1 |
| Repetition
Rate | 5Hz | ET LightSheer
1060 handpiece:
Up to 3Hz
High Speed
LightSheer 1060
handpiece: Up to
3Hz | 1-10Hz | Similar1 |
| Maximum
energy
density of a
single pulse | LHR-V6S-1064:
5J/cm2, 6 J /cm2,
7J/cm2
LHR-V6S/B-1064:
4J/cm2, 5J/cm2,
6J/cm2 | ET LightSheer
1060 handpiece:
10-100 J/cm2
High Speed
LightSheer 1060
handpiece:
4.5-14 J/cm2 | 14.0J/cm2 (under
20mm handpiece
spot size) | Similar2 |
| Handpiece
Spot Size | 30mm×10mm | ET LightSheer
1060 handpiece:
9mm×9mm
High Speed
LightSheer 1060
handpiece: 22
mm×35mm | 3mm, 5mm,
7mm, 10mm,
12mm, 15mm,
18mm, 20mm,
22mm & 24mm | Similar3 |
| Working
Area | 3cm2 | ET LightSheer
1060 handpiece:
0.81cm2
High Speed
LightSheer 1060
handpiece:
7.7cm2 | 3.14cm2 (under
20mm handpiece
spot size) | Similar3 |
| Input
Voltage | AC100-240V,
50/60Hz, 1.6A | AC100-240V,
50/60Hz, 10A,
Single Phase | 208/240VAC,
30A, 50/60Hz,
Single Phase | Similar4 |
Wuhan Lotuxs Technology Co., Ltd.
Note 1: Pulse Width and Repetition Rate of the proposed device are similar to those of the primary predicate device K133319 and secondary predicate device K141425.
7
These slight differences do not affect to safety and effectiveness of the proposed device.
Note 2: Maximum energy density of a single pulse of the proposed device is similar to those of the primary predicate device K133319. These slight differences do not affect to safety and effectiveness of the proposed device.
Note 3: Handpiece Spot Size of the proposed device is similar to that of High Speed LightSheer 1060 handpiece of the primary predicate device K133319. Working Area of the proposed device is similar to that of the secondary predicate device K141425. These slight differences do not affect to safety and effectiveness of the proposed device.
Note 4: Input Voltage of the proposed device is similar to those of the primary predicate device K133319 and the secondary predicate device K141425. These slight differences do not affect to safety and effectiveness of the proposed device.
Discussion for Substantially Equivalent (SE):
The proposed device Diode Laser Hair Removal LHR-V6S-1064, LHR-V6S/B-1064 has the same indications for use, laser type, wavelength, treatment activation, prescription, handpiece spot size, working area. The difference exists in such contents: pulse width, repetition rate, maximum energy density of a single pulse, input voltage. These items can be controlled within the scope of application. These slight differences between the proposed devices and predicate devices do not cause new safety and effectiveness problems. According to the non clinical test results on safety and effectiveness in the proposed indication of hair removal, the proposed device is as safe, effective and has good performance as the predicate device.
So the proposed device is Substantially Equivalent (SE) to the predicate device which is US legally market device.
8. Non-Clinical Tests Submitted
The following non-clinical testing was provided in this 510(k) submission:
Biocompatibility Testing
According to ISO 10993-1:2018, we performed biocompatibility test for the parts that may directly contact the intact skin of the patient or operator, including in vitro cytotoxicity test per ISO 10993-5:2009, skin sensitization test per ISO 10993-10:2021, irritation test per ISO 10993-23:2021.
Electrical Safety and Electromagnetic Compatibility Testing
The propoesd device was tested and complied with the applicable requirements of the following standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-22 and IEC 60825-1, demonstrated that the basic safety and performance of the device met the requirements.
Software Verification and Validation
Software verification and validation was performed, and it was demonstrated that the software performs as intended according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
9. Concise summary for performance testing
From the performance testing - bench, we have a brief summary as follow: 1. Performance Test: Appearance, Function, Safety, Label.
8
-
Shelf Life Test: Accelerated aging test, and performance test after accelerated aging test).
-
Cleaning and Disinfection Verification: Simulated cleaning and disinfection test, and performance test after simulated cleaning and disinfection test.
All the bench test results are provided in Performance Test Report.
10. Clinical Study
No clinical testing has been performed.
11. Conclusions
The summary includes the conclusions drawn from the nonclinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device. 807.92(b)(3)