DermRays Revive is intended for hair reduction. Permanent hair reduction is defined as the longterm, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

DermRays Revive is also intended for treatment of wrinkles.

DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

Device Description

DermRays Revive uses a diode laser with an output wavelength of 1064nm, to act on the dermis through the epidermis, and the laser energy is absorbed by the target tissues (melanin, hemoglobin, and water).

Due to the selective photothermal effect of the laser, it can treat wrinkles, without damaging the skin. Simutaneously, the laser can act on the melanin in the hair follicles, destroy hair follicles in the growth around the hair follicles, so as to remove hairs.

The device consists of a power adapter, a power cord and a main unit.

AI/ML Overview

The provided text is a 510(k) summary for the DermRays Revive device, which is a laser surgical instrument. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through a clinical trial or extensive performance testing with clearly defined metrics.

Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes, expert ground truth establishment, and MRMC studies are not present in this document because they are generally not required for a 510(k) submission that relies on demonstrating substantial equivalence to existing predicate devices, especially when no clinical testing was performed.

However, based on the information provided, here's what can be extracted and what is explicitly stated as not performed:

1. A table of acceptance criteria and the reported device performance

The document does not provide a specific table of quantitative "acceptance criteria" for the device's clinical performance (e.g., a specific percentage of hair reduction or wrinkle improvement expected). Instead, it demonstrates substantial equivalence to predicate devices based on shared technical characteristics and intended use. The "performance" assessment is primarily through non-clinical testing to ensure safety and functionality.

The table presented (Table 1) is a comparison of the proposed device's technical specifications and intended uses against its predicate devices, not acceptance criteria for clinical efficacy.

Table 1: Comparison of Proposed Device (DermRays Revive) with Predicate Devices (Summary)

Characteristic	Proposed Device (DermRays Revive)	Primary Predicate (Cynosure Elite+ Laser)	Secondary Predicate (Diode Laser Hair Removal)	Comparison
Acceptance Criteria/Performance Metrics (as per document)	Not explicitly defined as quantitative clinical metrics. The acceptance is based on demonstrating substantial equivalence regarding:
Indications for Use	Hair reduction, permanent hair reduction (at 6, 9, 12 months), wrinkle treatment; all skin types (I-VI), including tanned skin.	Hair reduction, permanent hair reduction (at 6, 9, 12 months), wrinkle treatment, various skin/vascular/pigmented lesions.	Hair reduction, permanent hair reduction (at 6, 9, 12 months); all skin types (I-VI), including tanned skin.	Same/Similar
Laser Type	Solid state	Solid state	Solid state	Same
Wavelength	1064nm±10nm	1064nm±10nm	1064nm±10nm	Same
Pulse Width	400ms	0.1ms-300ms	LHR-V6S-1064: 350ms-450ms; LHR-V6S/B-1064: 280ms-400ms	Same (to one secondary predicate model)
Single Pulse Max. Energy Density	5.0J/cm² - 10.0J/cm²	4.7J/cm² (24mm spot) - 12.0J/cm² (15mm spot)	LHR-V6S-1064: 5J/cm², 6J/cm², 7J/cm²; LHR-V6S/B-1064: 4J/cm², 5J/cm², 6J/cm²	Similar (Differences do not affect safety/effectiveness)
Handpiece Spot Size	15mm	3mm, 5mm, 7mm, 10mm, 12mm, 15mm, 18mm, 20mm, 22mm & 24mm	30mm×10mm	Same (to 15mm option of primary predicate)
Working Area	1.766cm²	4.522cm² (24mm spot) - 1.766cm² (15mm spot)	3cm²	Same (to 15mm option of primary predicate)
Input Voltage	AC100-240V, 50/60Hz, 1.6A Max.	208/240VAC, 30A, 50/60Hz, Single Phase	AC100-240V, 50/60Hz, 1.6A Max.	Same

Study Proving Device Meets Acceptance Criteria:

The study proving the device's substantial equivalence and suitability for market is detailed through non-clinical testing as follows:

Biocompatibility Testing: Performed on parts contacting skin (ISO 10993-1, -5, -10, -23)
Electrical Safety and Electromagnetic Compatibility (EMC) Testing: Conformance to 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.
Performance Testing - Bench: Appearance, Function, Safety, Label.
Shelf Life Test: Accelerated aging test and subsequent performance test.
Cleaning and Disinfection Verification: Simulated cleaning and disinfection test and subsequent performance test.

The document explicitly states: "No clinical testing has been performed." This is a critical point for the remaining questions.

2. Sample sizes used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of a clinical test set, as no clinical testing was performed. The non-clinical tests involved samples of the device and its components.
Data Provenance: The general context of the submission implies that all testing (biocompatibility, electrical safety, software, bench performance) was conducted by or for Wuhan Lotuxs Technology Co., Ltd. (China). The document does not specify whether these tests were done retrospectively or prospectively, but typically, pre-market non-clinical testing for a 510(k) is performed prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: Since no clinical studies were performed, there was no "ground truth" to establish for a test set by human experts (like radiologists for imaging devices). The ground truth for the non-clinical tests is based on adherence to established engineering, safety, and performance standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable: No clinical test set requiring expert adjudication was utilized.

5. 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

No: The document explicitly states "No clinical testing has been performed." Therefore, no MRMC study was conducted, and no human-AI interaction or improvement was assessed. The device described is a laser instrument, not an AI diagnostic or assistance tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable: This device is a physical laser instrument. While it has software, its "performance" is primarily mechanical and energy delivery, not an algorithm providing a diagnostic or analytical output that would have a standalone performance metric in the way AI algorithms do. The software verification and validation ensured the software performs as intended for device operation, not as a standalone analytical tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable for Clinical Performance: As no clinical studies were performed, there was no clinical "ground truth" established from expert consensus, pathology, or outcomes data for efficacy.
For Non-Clinical Tests: The "ground truth" for the non-clinical tests is defined by the requirements of the standards themselves (e.g., maximum allowable cytotoxicity, specific electrical safety thresholds, software functionality specifications).

8. The sample size for the training set

Not Applicable: There is no mention of a "training set" for an algorithm in the context of this laser device submission.

9. How the ground truth for the training set was established

Not Applicable: As no training set was mentioned.

Summary

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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.

January 30, 2024

Wuhan Lotuxs Technology Co., Ltd. Na Wu, Quality Manager 501/E2, No.999 High-tech Avenue Wuhan, Hubei 430206 China

Re: K231910

Trade/Device Name: DermRays Revive 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: December 13, 2023 Received: December 13, 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.

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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 (OS) 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 medical devices and radiation-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).

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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-devices/deviceadvice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tanisha L. Hithe Tanisha L. s 2024.01.30 Hithe -S 14:57:30 -05'00'

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

Enclosure

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Indications for Use

510(k) Number (if known) K231910

Device Name DermRays Revive (LHR-S5-1064)

Indications for Use (Describe)

DermRays Revive is also intended for treatment of wrinkles.

DermRays Revive 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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Section 5 - 510(k) Summary K231910

Date of Summary Preparation: June 25, 2023 Date of Summary Modification: January 09, 2024

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: DermRays Revive Model: LHR-S5-1064 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: K141425 Cynosure Elite+ Laser Secondary predicate device: K232117 Diode Laser Hair Removal

5. Device Description

The device consists of a power adapter, a power cord and a main unit.

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6. Intended Use of Device

DermRays Revive 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. DermRays Revive is also intended for treatment of wrinkles.

DermRays Revive is intended for use on all skin types (Fitzpatrick skin types I - VI), including tanned skin.

7. Summary of Substantial Equivalence

	Proposed device	Primary predicatedevice	Secondary predicatedevice	Comparison
510kNumber	K231910	K141425	K232117	—
ProductCode	GEX	GEX	GEX	—
ProprietaryName	DermRays Revive	Cynosure Elite+ Laser	Diode Laser HairRemoval	—
Model	LHR-S5-1064	/	LHR-V6S-1064,LHR-V6S/B-1064	—
Manufacture	Wuhan LotuxsTechnology Co., Ltd.	Cynosure LLC	Wuhan LotuxsTechnology Co., Ltd.	—
Indicationsfor use	DermRays Revive isintended for hairremoval, permanenthair reduction.Permanent hairreduction is defined asthe long-term, stablereduction in the numberof hairs regrowingwhen measured at 6, 9,and 12 months after thecompletion of atreatment regime.DermRays Revive isalso intended fortreatment of wrinkles.DermRays Revive isintended for use on allskin types (Fitzpatrickskin types I - VI),including tanned skin.	1064 nm:The Cynosure Elite+Laser is intended forthe coagulation andhemostasis of benignvascular lesions suchas, but not limited to,port wine stains,hemangiomas, warts,telangectasia, rosacea,venus lake, leg veins,spider veins andpoikiloderma of civatte;and treatment of benigncutaneous lesions suchas warts, scars, striaeand psoriasis. The laseris also intended for thetreatment of benignpigmented lesions suchas, but not limited to,lentigos (age spots),solar lentigos (sun	Diode Laser HairRemoval(LHR-V6S-1064,LHR-V6S/B-1064) isintended for hairremoval, permanenthair reduction.Permanent hairreduction is defined asthe long-term, stablereduction in the numberof hairs regrowingwhen measured at 6, 9,and 12 months after thecompletion of atreatment regime.Diode Laser HairRemoval(LHR-V6S-1064,LHR-V6S/B-1064) isintended for use on allskin types (Fitzpatrickskin types I - VI),	Same

		spots), cafe au laitmacules, seborrheickeratoses, nevi,chloasma, verrucae,skin tags, keratosis andplaques.The laser is alsoindicated for thetreatment of wrinklessuch as, but not limitedto, periocular andperioral wrinkles.Additionally, the laseris indicated for the
		treatment ofpseudofolliculitisbarbae (PFB) and forstable long-term, orpermanent hairreduction. Permanenthair reduction isdefined as long-termstable reduction in thenumber of hairsregrowing whenmeasured at 6, 9 and 12months after thecompletion of atreatment regime.	including tanned skin.
Laser Type	Solid state	Solid state	Solid state	Same
Wavelength	1064nm±10nm	1064nm±10nm	1064nm±10nm	Same
TreatmentActivation	Fingerswitch	Fingerswitch	Fingerswitch	Same
Rx/OTC	Prescription	Prescription	Prescription	Same
Pulse Width	400ms	0.1ms-300ms	LHR-V6S-1064:350ms-450msLHR-V6S/B-1064:280ms-400ms	Same1
Single PulseMax. EnergyDensity	$5.0J/cm^2$ - $10.0J/cm^2$	$4.7J/ cm^2$ (under 24mmhandpiece spot size)$12.0J/cm^2$ (under 15mmhandpiece spot size)	LHR-V6S-1064:$5J/cm^2$ , $6 J /cm^2$ , $7J/cm^2$LHR-V6S/B-1064:$4J/cm^2$ , $5J/cm^2$ , $6J/cm^2$	Similar2

HandpieceSpot Size	15mm	3mm, 5mm, 7mm,10mm, 12mm, 15mm,18mm, 20mm, 22mm& 24mm	30mm×10mm	Same3
WorkingArea	1.766cm2	4.522cm2 (under 24mmhandpiece spot size)1.766cm2 (under 15mmhandpiece spot size)	3cm2	Same3
InputVoltage	AC100-240V,50/60Hz, 1.6A Max.	208/240VAC, 30A,50/60Hz, Single Phase	AC100-240V,50/60Hz, 1.6A Max.	Same4

Table 1

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Note 1: Pulse Width of the proposed device is same as the secondary predicate device LHR-V6S/B-1064 of K232117.

Note 2: Maximum energy density of a single pulse of the proposed device is similar to those of the primary predicate device K141425 (1064nm) and secondary predicate device K232117. These slight differences do not affect to safety and effectiveness of the proposed device.

Note 3: Handpiece Spot Size and Working Area of the proposed device are same to those of the secondary predicate device K141425 (15mm, 1.766 cm-).

Note 4: Input Voltage of the proposed device is same as the secondary predicate device K232117.

Discussion for Substantially Equivalent (SE):

The proposed device DermRays Revive LHR-S5-1064 has the same indications for use, laser type, wavelength, treatment activation, prescription, pulse width, handpiece spot size and working area, input voltage; has similar single pulse max. energy density. These different 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 and use evaluation report, 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

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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 complicable 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:

Performance Test: Appearance, Function, Safety, Label.
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

After analyzing both bench and external laboratory testing data, the intended use and supporting data can conclude that the device in the submission is substantially equivalent to the predicate device.

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.