LaserME by Neauvia North America

The LaserMe is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The LaserMe is further indicated for treatment of benign pigmented lesions, such as, but not limited to lentigines (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.

Device Description

LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.

AI/ML Overview

The provided text is a 510(k) summary for the LaserME device. It details the device's indications for use, specifications, and comparison to a predicate device (Emerge Fractional Laser K111840).

The concept of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as typically applied to performance metrics of an AI/ML medical device (e.g., sensitivity, specificity, AUC) is not directly present in this document. This submission is for a laser surgical instrument, not an AI/ML device, and therefore the "acceptance criteria" relate more to safety, performance against engineering specifications, and biological compatibility rather than statistical performance metrics of a diagnostic or assistive AI.

However, I can extract the relevant "testing" components that demonstrate the device meets its intended use and safety standards, and present them in a way that aligns with your request for how the device proves it meets acceptance criteria, even if those criteria are not presented in a tabular format of "performance metrics" in the AI sense.

Here's an interpretation based on the provided document, addressing the closest equivalents to your requested points:

Acceptance Criteria and Device Performance for LaserME

Given that the LaserME is a laser surgical instrument, the "acceptance criteria" are not framed in terms of traditional AI/ML performance metrics (e.g., sensitivity, specificity, AUC). Instead, they are related to its functional specifications, safety standards, and biological effects, demonstrating substantial equivalence to a predicate device.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical and clinical testing performed to satisfy regulatory requirements for substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Category / Acceptance Criteria Type	Reported Device Performance / Testing Result
Engineering Specifications (Comparison to Predicate)
Laser Type: Diode	LaserME: Diode; Predicate: Diode
Power Supply: 110-240 VAC, 50/60Hz (general range for medical devices)	LaserME: 112-240 VAC, 50/60Hz; Predicate: 110-240 VAC, 50/60Hz
Output Wavelength: Within therapeutic range (e.g., 1410-1470nm for fractional skin resurfacing)	LaserME: 1470 +/- 20nm; Predicate: 1410nm
Pulse Time: Suitable for controlled tissue interaction	LaserME: 30ms; Predicate: Max 20ms (NOTE: The higher pulse time for LaserME is noted, suggesting it was deemed acceptable despite difference from predicate, likely due to safety/efficacy demonstration in other tests).
Applicator Window Size: Comparable to predicate for similar treatment area	LaserME: 12 x 12mm; Predicate: 12mm x 8mm (Comparable, slightly larger area).
Energy Output: Within therapeutic range for intended dermatological procedures	LaserME: 5mJ-50mJ; Predicate: 10mJ to 30mJ (LaserME has a wider energy range, including higher maximum, but lower minimum. This would be evaluated for safety and efficacy in the non-clinical and clinical tests).
Number of Microbeams: Comparable density for fractional treatment	LaserME: Up to 70; Predicate: Up to 70
Repetition Frequency: Suitable for efficient treatment application	LaserME: Up to 18Hz; Predicate: Up to 30Hz (LaserME has a lower max frequency. This is a functional difference that was submitted as acceptable).
Weight & Dimensions: Manageable for clinical use	LaserME: 4 Kg, 156 x 335 x 421 mm; Predicate: Handpiece: 250 g, Base: 3 kg, Dimensions: Unknown (Overall comparable system weight).
Indications for Use: Substantially equivalent to predicate	LaserME: Coagulation of soft tissue, skin resurfacing, treatment of benign pigmented lesions (lentigines, solar lentigos, melasma, dyschromia), and facial wrinkles/fine lines. Predicate: Same indications for use.
Safety and Performance Standards (Non-Clinical Testing)
Electrical Safety: Compliance with IEC 60601-1 (General requirements for basic safety and essential performance)	Performed: IEC 60601-1 Test for Medical Electrical equipment was performed.
Electromagnetic Compatibility (EMC): Compliance with IEC 60601-1-2	Performed: IEC 60601-1-2 Test for Medical Equipment was performed.
Laser Specific Safety: Compliance with IEC 60601-2-22 (Particular requirements for surgical, cosmetic, therapeutic, and diagnostic laser equipment)	Performed: IEC 60601-2-22 Test was performed.
Biocompatibility: Compliance with ISO 10993-1 (Biological Evaluation of Medical Devices)	Performed: ISO 10993-1 Biological Evaluation of Medical Devices was performed.
Dermal Tissue Interaction: Demonstrable comparable tissue damage profile at worst-case energy to predicate	Performed: Histological assessment in ex vivo tissue to demonstrate that the extent of the damage induced due to the worst-case pulse energy of the subject device is comparable to the damage induced due to the worst-case pulse energy of the predicate device. Result (Implied): Deemed comparable.
Clinical Performance (Clinical Testing)
Thermal Effects and Tissue Healing Process: Device behaves as intended on human tissue	Performed: Evaluated in 18 healthy volunteers. Subjects exposed to a single laser treatment, followed by histology analysis performed immediately, 3, and 10 days post-treatment. Result: "The study results show that the LaserMe behaved as intended." This implies the thermal effects and healing were safe and consistent with the intended mechanism of action for resurfacing.

Study Details (As applicable to a laser device submission):

For a laser device, the "study" is primarily focused on demonstrating safety, functional performance, and substantial equivalence to a legally marketed predicate, rather than the statistical performance of an AI model.

2. Sample Size Used for the Test Set and Data Provenance

Non-Clinical Testing:
- Ex vivo tissue: Sample size not specified.
- Provenance: Not specified (but implied to be laboratory-based).
Clinical Testing:
- Sample Size: 18 healthy volunteers.
- Data Provenance: Not specified regarding country of origin, but described as a prospective clinical study.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Non-Clinical (Histological Assessment): The document implies expert assessment of the ex vivo histological samples, but the number of experts and their qualifications are not specified. This would typically be performed by pathologists or dermatopathologists.
Clinical (Histology Analysis from Human Subjects): Histology analysis was performed, implying expert review (likely pathologists), but the number of experts and their qualifications are not specified.

4. Adjudication Method for the Test Set

Not Applicable in the AI/Ground Truth Sense: For this type of device, "adjudication" wouldn't be relevant for a test set in the same way it is for diagnostic AI models (e.g., resolving discrepancies in expert labels). The histological and clinical assessments provide direct evidence of tissue response.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No: This type of study (comparing human readers with and without AI assistance) is not applicable as the LaserME is a therapeutic/surgical device, not a diagnostic AI.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

Yes, by nature of the device: The non-clinical and certain aspects of clinical testing assess the performance of the device itself (its laser output, tissue interaction, safety, healing properties) independently of direct human interpretive "performance" in a diagnostic context. The device performs its function directly.

7. Type of Ground Truth Used

Non-Clinical: Histological assessment in ex vivo tissue provided "ground truth" regarding the extent of laser-induced damage.
Clinical: Histology analysis from human subjects provided "ground truth" on in vivo thermal effects and tissue healing. "Behaved as intended" serves as the primary outcome.

8. Sample Size for the Training Set

Not Applicable: This is a physical device, not an AI/ML model that requires a "training set" in the computational sense. Development of laser parameters and designs would be based on engineering principles and prior scientific understanding, not a data-driven training set.

9. How the Ground Truth for the Training Set Was Established

Not Applicable: See point 8.

Summary

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July 17, 2023

Neauvia North America Joy Willard Director of Quality, Regulatory, and Clinical Affairs 8480 Honevcutt Road Raleigh, North Carolina 27615

Re: K230077

Trade/Device Name: LaserME 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: June 15, 2023 Received: June 16, 2023

Dear Joy Willard:

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 (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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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). 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/5 description: The image shows the name "Jianting Wang -S" in a large, clear font. The text is horizontally oriented and appears to be the primary focus of the image. The background is plain, ensuring the text is easily readable.

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230077

Device Name LaserME

Indications for Use (Describe)

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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This 510(K) Summary of safety and effectiveness for the LaserME is submitted in accordance with the requirements of 21 CFR 807.92.

Applicant: Neauvia North America Address: Neauvia North America 8480 Honeycutt Road Raleigh, NC 27615 Contact Person: Joy Willard Contact Information: 984-777-5296 joy@neauvia-us.com Preparation Date: January 23, 2022 Device Trade Name: LaserME Powered laser surgical instrument Common Name: Regulation Name: 21 CFR 878.4810, Laser Surgical Instrument for use in general and plastic surgery and in dermatology Product Codes: GEX Emerge Fractional Laser K111840 Legally Marketed Predicate Device: Regulatory Class: Class II Prescription Use Description of the LaserME Laser LaserME is a non-ablative diode laser. The device is equipped with a diode laser with a wavelength of 1470 System: nm and a maximum power of 2W, intended for nonablative skin resurfacing. The device works by punctuating the skin (epidermis) with several micro laser beams. The points are evenly spaced with adjustable spacing from 1mm to 4mm. The energy delivered to a single point is regulated from 5mJ to 50mJ.

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Intended use of LaserME

Specifications	LaserME	Emerge Fractional Laser K111840
Laser type	Diode	Diode
Power Supply	112-240 VAC, 50/60Hz	110-240 VAC, 50/60Hz
Output wavelength	1470 +/- 20nm	1410nm
Pulse Time	30ms	Max 20ms
Applicator Window	12 x 12mm	12mm x 8mm
Energy	5mJ-50mJ	10mJ to 30mJ
No. of microbeams	Up to 70	Up to 70
RepetitionFrequency	Up to 18Hz	Up to 30Hz
Weight	4 Kg	Handpiece: 250 gBase: 3 kg
Dimensions	156 x 335 x 421 mm	Unknown
Indications for use	The LaserMe is intended for usein dermatological proceduresrequiring coagulation of softtissue and skin resurfacingprocedures. The LaserMe isfurther indicated for treatmentof benign pigmented lesions,such as, but not limited tolentigines (age spots), solarlentigos (sun spots), melasma,dyschromia, and for treatment offacial wrinkles and fine lines.	The Emerge Fractional Laser isintended for use in dermatologicalprocedures requiring coagulationof soft tissue and skin resurfacingprocedures. The Emerge FractionalLaser is further indicated fortreatment of pigmented lesions,such as, but not limited to lentigos(age spots), solar lentigos (sunspots), melasma, dyschromia, andfor treatment of facial wrinkles andfine lines.
Non-clinical Testing:		The following performance data was provided insupport of the substantial equivalence determination:IEC 60601-1 Test for Medical Electrical equipmentwas performed for General Requirements for basicsafety and essential performance.

Comparison to the Predicate Device:

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	IEC 60601-1-2 Test for Medical Equipment forGeneral Requirements for basic safety and essentialperformance: electromagnetic compatibility
	IEC 60601-2-22 Test for Particular requirements forbasic safety and essential performance of surgical,cosmetic, therapeutic and diagnostic laser equipment
	ISO 10993-1 Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testing Within a RiskManagement Process
	Histological assessment in ex vivo tissue todemonstrate that the extent of the damage induced dueto the worst-case pulse energy of the subject device iscomparable to the damage induced due to the worst-case pulse energy of the predicate device.
Clinical Testing:	The thermal effects of the LaserME and tissue healingprocess were evaluated in 18 healthy volunteers. Thestudy was conducted by exposing human subjects to asingle laser treatment followed by histology analysisperformed immediately, 3 and 10 days post treatment.The study results show that the LaserMe behaved asintended.

Conclusion: Based on the comparison and analysis above, the proposed subject device LaserME is determined to be Substantially Equivalent (SE) 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.