Who is the manufacturer of Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Wuhan Lotuxs Technology Co., Ltd. filed the 510(k) submission for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064) (K232117).

What is the FDA product code for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

ET LightSheer 1060 and High Speed LightSheer 1060 (K133319); Cynosure Elite+ Laser (K141425).

Who can help prepare an FDA 510(k) submission like Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)

K232117 · Wuhan Lotuxs Technology Co., Ltd. · GEX · Nov 28, 2023 · General, Plastic Surgery

Device Facts

Record ID	K232117
Device Name	Diode Laser Hair Removal (LHR-V6S-1064, LHR-V6S/B-1064)
Applicant	Wuhan Lotuxs Technology Co., Ltd.
Product Code	GEX · General, Plastic Surgery
Decision Date	Nov 28, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

Intended 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.

Device Story

Device emits 1064nm infrared laser pulses to disrupt hair follicles via selective melanin absorption; creates localized thermal effect. Features skin contact sensor to enable emission only when touching skin; includes skin cooling. Powered by external AC/DC adapter. Operated by clinician in professional setting. Device output (laser pulses) used to achieve permanent hair reduction. Benefits patient through long-term hair regrowth reduction.

Clinical Evidence

No clinical data. Evidence based on non-clinical bench testing, including performance, shelf-life, and cleaning/disinfection verification, alongside biocompatibility (ISO 10993) and electrical safety/EMC (IEC 60601 series) testing.

Technological Characteristics

Solid-state diode laser; 1064nm wavelength. Handpiece spot size 30mm x 10mm. Powered by external AC/DC adapter (100-240V). Contact sensor for emission control. Biocompatibility per ISO 10993-5, -10, -23. Electrical safety per IEC 60601-1, -1-2, -1-11, -2-22; laser safety per IEC 60825-1.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

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.

Predicate Devices

ET LightSheer 1060 and High Speed LightSheer 1060 (K133319)
Cynosure Elite+ Laser (K141425)

Related Devices

K251339 — Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04) · Zhengzhou PZ Laser Slim Technology Co., Ltd. · Jul 25, 2025
K222800 — Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone Standard-A) · Sanhe Laserconn Tech Co., Ltd. · Nov 7, 2022
K241547 — Diode Laser Therapy Device (DF-DIODE LASER-S1) · Weifang Dragonfly Electronics Technology Co., Ltd. · Aug 13, 2024
K220103 — LED Therapy Device (Planar LED/Planar LED mini) · Shenzhen Leaflife Technology Co., Ltd. · Apr 12, 2022
K232709 — Diode laser therapy device · Hebei Zhemai Technology Co., Ltd. · Nov 30, 2023

Submission Summary (Full Text)

{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) K232117 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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}------------------------------------------------ 2. Shelf Life Test: Accelerated aging test, and performance test after accelerated aging test). 3. 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)