The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser radiation with the wavelength of 445 nm (aiming beam 635 nm). A beam transporting system delivers this energy to affected surfaces and organs. Depending on the model, the LEONARDO® Mini Blue laser has the following maximum laser output power: LEONARDO® Mini Blue: 10W@445nm. LEONARDO® Mini Blue is available as a single-wavelength device with 445 nm. All LEONARDO® Mini Blue laser can be operated in continuous mode. Additional special treatment modes for specific treatment procedures or in combination with corresponding application fibers are available, depending on the configuration of the unit. For safety reasons, the LEONARDO® Mini Blue laser is equipped with a system for automatic recognition of the optical fibers used. Application fibers from CeramOptec have coding for communicating with the laser device.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Leonardo Mini Blue 445nm Laser. It focuses on demonstrating substantial equivalence to a predicate device (A.R.C. Laser GmbH Device Wolf 445nm K192272) rather than presenting a study of diagnostic accuracy or a specific set of acceptance criteria for an AI/CADe device.

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/CADe device (specifically, clinical study design elements like sample sizes, expert ground truth establishment, MRMC studies, standalone performance, and training set details) is not applicable to this submission.

This submission is for a surgical laser, and its demonstration of substantial equivalence relies on:

Comparison of Technical Characteristics: Showing that the Leonardo Mini Blue 445nm Laser has similar design, power, wavelength, and operational modes to the predicate device, with minor differences not affecting safety or effectiveness.
Compliance with Recognized Standards: Demonstrating the device meets relevant electrical safety, EMC, usability, and laser safety standards (e.g., IEC 60601 series, IEC 60825-1, ISO 14971).
Bench Testing: Stating that bench testing was performed and indicated the new device is as safe and effective as the predicate.
Software Validation: The firmware was validated according to the FDA Guidance for software in medical devices.

Summary of what is present in the document related to "acceptance criteria" (non-AI/CADe context):

A table of acceptance criteria and the reported device performance:
The document includes a "Substantial Equivalence Chart" (pages 4-5) which compares the characteristics of the Leonardo Mini Blue 445nm Laser (proposed device) to the A.R.C. Laser GmbH Device Wolf 445nm (predicate device). This serves as the "acceptance criteria" in the context of substantial equivalence for a medical device without an AI component.

Characteristic	Acceptance Criteria (Predicate Device)	Reported Device Performance (Proposed Device)	Compliance / Justification
Indications for Use	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	Incision, excision, vaporization, ablation, hemostasis, and coagulation of soft tissue.	SAME
Display	Touch Screen	Touch Screen	SAME
Mode	Diode Laser	Diode Laser	SAME
Laser Power	0.5 W up to 10 W	Up to 10 W	SAME
Laser Type	Diode Laser	Diode Laser	SAME
Wavelength	445 nm	445 nm	SAME
Aiming Beam	532 nm	635 nm	Both predicate and proposed device aiming beams are within the readily visible spectrum. No adverse safety or effectiveness impact.
Aiming Beam Power	≤ 5 mW	Max. 4 Mw	Comparable. No adverse safety or effectiveness impact.
Laser Class	4	4	SAME
Operation Mode	Pulsed, Continuous Wave (CW)	Pulsed, Continuous Wave (CW)	SAME
Pulse Length/Duration	≤ 4 Watt: 1 ms to 45 sec and CW> 4 Watt: 1 ms to 60 ms	10 Watt: 10 ms to 1 sec and CW.	Useful range for the indications. No adverse safety or effectiveness impact.
Pulse Frequency	≤ 4 Watt: 0.01 Hz to 500 Hz and SP> 4 Watt: 0.02 Hz to 6.6 Hz and SP	10 Watt: 0.5Hz - 50Hz	Useful range for the indications. No adverse safety or effectiveness impact.
Cooling	Air	Internal Fan.	No adverse safety or effectiveness impact.
Main Power Supply	100-240 V~, 47-63 Hz, 1.06-0.45 A	Mains operated OR Li-ion rechargeable battery.	No adverse safety or effectiveness impact.
Dimensions of System	H 10.06 cm, W 20.3 cm, 23.9 cm	H 6 cm, W 9 cm, L 21.5 cm.	SMALLER. No adverse safety or effectiveness impact.
Weight	2.8 kg (6.17 pounds)	0.960kg (without batteries) + 2x 0.045kg (battery weight)	LIGHTER WEIGHT. No adverse safety or effectiveness impact.

Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study for diagnostic accuracy on a test set. This is a comparison of technical specifications and compliance with standards.
Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for diagnostic performance is not established as no such study was conducted.
Adjudication method: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done as this is not an AI/CADe device requiring such a study to demonstrate improved reader performance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. This is not an AI/ML device trained on a dataset.
How the ground truth for the training set was established: Not applicable.

Instead, the document states:

"The results of bench testing indicate that the new device is as safe and effective as the predicate device." (Page 5, Section 6)
"Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Software validation documents were provided for a moderate level of concern." (Page 5, Section 7)
Compliance with various recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-22, ISO 14971, IEC 62304) tested by an accredited laboratory (EZU) is cited as evidence of safety and effectiveness. (Pages 5-6, Section 7)
"Clinical testing was not required to establish substantial equivalence." (Page 6, Section 8)

Summary

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September 1, 2021

CeramOptec GmbH % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K210951

Trade/Device Name: Leonardo Mini Blue 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: March 28, 2021 Received: March 30, 2021

Dear Daniel Kamm:

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.

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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 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.

Purva Pandya 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) K210951

Device Name Leonardo Mini Blue 445nm Laser

Indications for Use (Describe)

The Leonardo Mini Blue 445nm Laser is intended for incision, vaporization, ablation, hemostasis and coagulation of soft tissue.

Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: 510(k) Number K210951 CeramOptec GMBH Siemensstrabe 44 Bonn Nordrhein-Westfalen, Bonn, Germany D-53121 Registration Number: 3003340844 Phone Number: +49 (228) 97 967 - 0 Date Prepared: August 31, 2021 Contact: Dr. Roland Dreschau, Director

1. Identification of the Device: Trade/Device Name: Leonardo® Mini Blue 445nm Laser 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
1. Equivalent legally marketed device: K192272, A.R.C. Laser GmbH Trade/Device Name: Wolf 445nm 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
1. Reference Devices (Sterile Single Patient Use Fiberoptic Probes) Biolitec Medical Devices, Inc.: MegaBeam ENT Probe: K113858., 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 and Biolitec Medical Devices, Inc.: MegaBeam 400 Micron Forward fire: K113709. 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
1. Indications for Use: The Leonardo Mini Blue 445nm Laser is intended for incision, excision, vaporization, ablation, hemostasis and coagulation of soft tissue.
1. Description of the Device: The laser family LEONARDO® Mini Blue is a laser system with functions and ergonomics specially developed for medical applications. A control panel is used to set treatment

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parameters, such as laser power. User-friendly menu navigation ensures a reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The fiber-coupled semiconductor laser diodes convert electrical energy to coherent laser radiation with the wavelength of 445 nm (aiming beam 635 nm). A beam transporting system delivers this energy to affected surfaces and organs. Depending on the model, the LEONARDO® Mini Blue laser has the following maximum laser output power:

LEONARDO® Mini Blue: 10W@445nm

LEONARDO® Mini Blue is available as a single-wavelength device with 445 nm. All LEONARDO® Mini Blue laser can be operated in continuous mode. Additional special treatment modes for specific treatment procedures or in combination with corresponding application fibers are available, depending on the configuration of the unit. For safety reasons, the LEONARDO® Mini Blue laser is equipped with a system for automatic recognition of the optical fibers used. Application fibers from CeramOptec have coding for communicating with the laser device.

Characteristic	A.R.C. Laser GmbHDevice Wolf 445nm K192272	CeramOptec GMBHLeonardo® Mini Blue 445nm Laser
Indications forUse	The Wolf 445 nm is intended for incision,excision, vaporization, ablation, hemostasisand coagulation of soft tissue.	The Leonardo Mini Blue 445nm Laser isintended for incision, excision, vaporization,ablation, hemostasis and coagulation of softtissue. SAME
Photo	Image: A.R.C. Laser GmbH Device Wolf 445nm K192272	Image: CeramOptec GMBH Leonardo® Mini Blue 445nm Laser
Display	Touch Screen	Touch Screen SAME
Mode	Diode Laser	Diode Laser SAME
Laser power	0.5 W up to 10 W	Up to 10 W SAME
Laser type	Diode Laser	Diode Laser SAME
Wavelength	445 nm	445 nm SAME

Substantial Equivalence Chart

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Characteristic	A.R.C. Laser GmbHDevice Wolf 445nm K192272	CeramOptec GMBHLeonardo® Mini Blue 445nm Laser
Aiming beam	532 nm	635 nm Both predicate and proposeddevice aiming beams are within thereadily visible spectrum. No adversesafety or effectiveness impact.
Aiming beampower	≤ 5 mW	Max. 4 Mw. Comparable. No adverse safetyor effectiveness impact.
Laser Class	4	4
Operationmode	Pulsed, Continuous Wave (CW)	Pulsed, Continuous Wave (CW) SAME
Pulse length/duration	≤ 4 Watt: 1 ms to 45 sec and CW> 4 Watt: 1 ms to 60 ms	10 Watt: 10 ms to 1 sec and CW.Useful range for the indications. No adversesafety or effectiveness impact.
Pulsefrequency	≤ 4 Watt: 0.01 Hz to 500 Hz and SP> 4 Watt: 0.02 Hz to 6.6 Hz and SP	10 Watt: 0.5Hz - 50HzUseful range for the indications. No adversesafety or effectiveness impact.
Cooling	Air	Internal Fan. No adverse safety oreffectiveness impact.
Main powerSupply	100-240 V~, 47-63 Hz, 1.06-0.45 A	Mains operated OR Li-ion rechargeablebattery. No adverse safety or effectivenessimpact.
Dimensions ofsystem	H 10.06 cm (3.9 inches), W 20.3 cm (7.9inches), 23.9 cm (9.4 inches)	H 6 cm, W 9 cm, L 21,5 cm. SMALLER. Noadverse safety or effectiveness impact.
Weight	2.8 kg (6.17 pounds)	0.960kg (without batteries)2x 0.045kg (battery weight)LIGHTER WEIGHT No adverse safety oreffectiveness impact.

1. The technological characteristics are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate device.

7) Summary of non-clinical testing:

Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Software validation documents were provided for a moderate level of concern. This device complies with the applicable portions of the standards listed below:

21 CFR Part 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

EN 1041:2008 Information Supplied By The Manufacturer Of Medical Devices

ISO 14971: 2007 Medical devices — Application of risk management to medical devices FDA # 5-40

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IEC ISO 15223-1:2016 (Corrected Version 2017-03) Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements FDA # 5-117

IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.

IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

IEC 60601-2-22: 2007+A1:2012 Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment FDA # 12-268

IEC 62304: 2006 Medical device software - Software life cycle processes

IEC 62366-1:2007+A1:2014 Medical devices - Part 1: Application of usability engineering to medical devices FDA # 5-114

IEC 60825-1: 2007 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)] FDA # 12-273

The IEC standards testing was conducted by an accredited testing laboratory "EZU".

1. Summary of clinical testing: Clinical testing was not required to establish substantial equivalence.
1. Conclusion: After analyzing bench and clinical tests, it is the conclusion of CeramOptec GMBH that the new CeramOptec GMBH Leonardo® Mini Blue 445nm Laser is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it 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.