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 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.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and studies demonstrating device performance:

Unfortunately, the provided document does not contain information about acceptance criteria for a specific performance metric (like accuracy, sensitivity, or specificity) of a diagnostic or AI-driven device, nor does it describe a study proving the device meets such criteria.

The document details a 510(k) premarket notification for a Diode Laser Hair Removal device (LHR-V6S-1064, LHR-V6S/B-1064). The focus of this submission is on demonstrating substantial equivalence to existing predicate devices based on technical characteristics, indications for use, and non-clinical safety testing.

Here's a breakdown of why the requested information isn't present and what information is provided:

Key Takeaways from the Document:

Device Type: It's a physical medical device (laser for hair removal), not a diagnostic or AI-powered software device.
Regulatory Pathway: 510(k) premarket notification, which relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness through extensive performance studies against specific acceptance criteria.
No Clinical Study: The document explicitly states: "No clinical testing has been performed." This directly indicates that there aren't clinical performance metrics or studies to assess against acceptance criteria.
Focus on Substantial Equivalence: The primary goal of the submission is to show that the proposed device is "as safe, as effective, and performs as well as or better than the predicate device" based on design, specifications, and non-clinical tests.

Response to your specific questions based on the provided document:

A table of acceptance criteria and the reported device performance:
- N/A. The document does not define specific performance acceptance criteria for a diagnostic or AI algorithm, nor does it report performance metrics against such criteria. The "performance testing" mentioned (Appearance, Function, Safety, Label, Shelf Life, Cleaning and Disinfection) are general bench tests for a physical device, not performance metrics like sensitivity or accuracy for a diagnostic.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. No clinical test set or data for performance evaluation (e.g., diagnostic accuracy) is mentioned because "No clinical testing has been performed."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. No clinical test set requiring ground truth established by experts is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No clinical test set requiring adjudication is mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- N/A. This device is for hair removal, not a diagnostic tool with AI assistance for human readers. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is a physical laser device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A. No clinical ground truth is established as no clinical studies were performed.
The sample size for the training set:
- N/A. This refers to a dataset for training an algorithm. This device is not an AI algorithm.
How the ground truth for the training set was established:
- N/A. As above, this is not an AI algorithm.

Information that is available about device equivalence and non-clinical testing:

Non-Clinical Tests Submitted:
- Biocompatibility Testing: According to ISO 10993-1:2018, including in vitro cytotoxicity (ISO 10993-5:2009), skin sensitization (ISO 10993-10:2021), and irritation (ISO 10993-23:2021). These tests were performed for parts contacting intact skin.
- Electrical Safety and Electromagnetic Compatibility Testing: Compliance 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 FDA guidance for software in medical devices.
Concise summary for performance testing (Bench Tests):
- Appearance, Function, Safety, Label.
- Shelf Life Test (accelerated aging).
- Cleaning and Disinfection Verification.

In summary, the provided document is a 510(k) clearance for a laser hair removal device, focusing on demonstrating substantial equivalence through technical specifications and non-clinical safety tests, not clinical performance against specific acceptance criteria for a diagnostic or AI device.

Summary

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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).

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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

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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.

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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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

6. Intended Use of Device

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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	Primarypredicate device	Secondarypredicate device	Comparison
510kNumber	K232117	K133319	K141425	—
ProductCode	GEX	GEX	GEX	—
ProprietaryName	Diode Laser HairRemoval	ET LightSheer1060 and HighSpeedLightSheer 1060	Cynosure Elite+Laser	—
Model	LHR-V6S-1064,LHR-V6S/B-1064	/	/	—
Manufacture	Wuhan LotuxsTechnology Co.,Ltd.	Lumenis Ltd.	Cynosure LLC	—
Indicationsfor use	Diode Laser HairRemoval(LHR-V6S-1064,LHR-V6S/B-1064)is intended for hairremoval,permanent hairreduction.Permanent hairreduction isdefined as thelong-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatment regime.Diode Laser HairRemoval(LHR-V6S-1064,LHR-V6S/B-1064)	ET LightSheer1060 and HighSpeedLightSheer 1060are intended fortreatment ofvascular lesions,includingangiomas,hemangiomas,telangiectasia,port wine stains,leg veins andother benignvascular lesions.ET LightSheer1060 and HighSpeedLightSheer 1060are intended forhair removal,permanent hairreduction, andthe treatment for	1064 nm:The CynosureElite+ Laser isintended for thecoagulation andhemostasis ofbenign vascularlesions such as,but not limitedto, port winestains,hemangiomas,warts,telangiectasia,rosacea, venuslake, leg veins,spider veins andpoikiloderma ofcivatte; andtreatment ofbenigncutaneouslesions such aswarts, scars	Same

Table 1

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is intended for useon all skin types(Fitzpatrick skintypes I - VI),including tannedskin.	PseudofolliculitisBarbae (PFB3).Permanent hairreduction isdefined as thelong-term, stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9,and 12 monthsafter thecompletion of atreatmentregime.ET LightSheer1060 and HighSpeedLightSheer 1060are intended forthe treatment ofbenignpigmentedlesions,including agespots, solarlentigines,eaf6-au-laitspots, nevi ofOtallto,melasma,Becker's neviand other benignpigmentedlesions.ET LightSheer1060 and HighSpeedLightSheer 1060are also intendedfor treatment ofwrinkles.ET LightSheer1060 and HighSpeedLightSheer 1060are intended foruse on all skintypes(Fitzpatrick skin	striae andpsoriasis. Thelaser is alsointended for thetreatment ofbenignpigmentedlesions such as,but not limitedto, lentigos (agespots), solarlentigos (sunspots), cafe aulait macules,seborrheickeratoses, nevi,chloasma,verrucae, skintags, keratosisand plaques.The laser is alsoindicated for thetreatment ofwrinkles such as,but not limitedto, periocularand perioralwrinkles.Additionally, thelaser is indicatedfor the treatmentofpseudofolliculitisbarbae (PFB)and for stablelong-term, orpermanent hairreduction.Permanent hairreduction isdefined aslong-term stablereduction in thenumber of hairsregrowing whenmeasured at 6, 9and 12 monthsafter thecompletion of atreatment

Wuhan Lotuxs Technology Co., Ltd.

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		types I - VI),including tannedskin.	regime.
Laser Type	Solid state	Solid state	Solid state	Same
Wavelength	1064nm±10nm	1060nm	1064nm±10nm	Same
TreatmentActivation	Fingerswitch	Footswitch orFingerswitch	Footswitch orFingerswitch	Same
Rx/OTC	Prescription	Prescription	Prescription	Same
Pulse Width	LHR-V6S-1064:350ms-450msLHR-V6S/B-1064:280ms-400ms	ET LightSheer1060 handpiece:5-400msHigh SpeedLightSheer 1060handpiece:30-400ms	0.1ms-300ms	Similar1
RepetitionRate	5Hz	ET LightSheer1060 handpiece:Up to 3HzHigh SpeedLightSheer 1060handpiece: Up to3Hz	1-10Hz	Similar1
Maximumenergydensity of asingle pulse	LHR-V6S-1064:5J/cm2, 6 J /cm2,7J/cm2LHR-V6S/B-1064:4J/cm2, 5J/cm2,6J/cm2	ET LightSheer1060 handpiece:10-100 J/cm2High SpeedLightSheer 1060handpiece:4.5-14 J/cm2	14.0J/cm2 (under20mm handpiecespot size)	Similar2
HandpieceSpot Size	30mm×10mm	ET LightSheer1060 handpiece:9mm×9mmHigh SpeedLightSheer 1060handpiece: 22mm×35mm	3mm, 5mm,7mm, 10mm,12mm, 15mm,18mm, 20mm,22mm & 24mm	Similar3
WorkingArea	3cm2	ET LightSheer1060 handpiece:0.81cm2High SpeedLightSheer 1060handpiece:7.7cm2	3.14cm2 (under20mm handpiecespot size)	Similar3
InputVoltage	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.

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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.

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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)

Regulation Number and Section

§ 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.