The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.

Urology

Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
Laser Resection of the Prostrate (LRP)
Laser Enucleation of the Prostate (LEP)
Laser Ablation of the Prostate (LAP)
Transurethral Incision of the Prostate (TUIP)
Condylomas
Urethral/ureteral structures
Lesions of external genitalia
Bladder neck incisions (BNI)
Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragmentation of renal calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology
Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitis
Haemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm Gynecology
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions

Gynecology
Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

Device Description

All variants of the laser family LEONARDO® Duster are laser systems with functions and ergonomics specially developed for medical applications. A touchscreen is used to set treatment parameters, such as Power in Continuous mode, Pulse energy (J) and Frequency (Hz) with Pulse width options in Pulse mode. User-friendly menu navigation and microprocessor-supported control ensure reliable operation while allowing physicians to concentrate on the essential aspects of treatment. The Thulium doped fiber laser module produce a coherent laser radiation with the wavelength of 1940nm±3nm (aiming beam 525nm +/-10nm). An optical fiber delivers this energy to affected surfaces and organs. All fields of application are listed in the indications for use statement.

The subject model LEONARDO® Duster laser has a maximum laser output power of 60W. @ 1940nm The LEONARDO® Duster is available only as a single-wavelength device with 1940nm. All LEONARDO® Duster lasers can be operated in two basic modes, CONTINUOUS or PULSE MODE. Two application modes are available which defines the intended use of the device: Lithotripsy and Other. For safety reasons, the LEONARDO® Duster laser is equipped with a system for automatic recognition of the used optical fibers. Application fibers from CeramOptec are RFID encoded for communicating with the laser device. Reusable fiber probes are available in 6 different sizes. They are initially EO sterilized. Subsequent sterilization is via autoclave. Single patient use fiber probes come in 7 different sizes. They are initially EO sterilized.

AI/ML Overview

This document is a 510(k) clearance letter for the Leonardo Duster laser system. It asserts substantial equivalence to a predicate device based on non-clinical testing. This type of clearance typically relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, often without requiring new clinical trials for effectiveness if the indications for use and technological characteristics are sufficiently similar.

Therefore, the provided text does not describe a study involving acceptance criteria related to device performance in a clinical or AI-centric context, nor does it present acceptance criteria for an AI-powered device. It primarily focuses on the safety and effectiveness of a physical medical device (a laser surgical instrument) compared to a predicate device, which is a common pathway for 510(k) clearance.

The "acceptance criteria" presented here are inferred from the regulatory requirements for 510(k) clearance, namely, demonstrating substantial equivalence to a predicate device based on:

Identical Indications for Use.
Similar technological characteristics without raising new questions of safety or effectiveness.
Compliance with relevant performance standards and non-clinical testing (e.g., software validation, reprocessing validation, biocompatibility, sterilization, electrical safety, EMC, usability, laser safety).

Since this is not an AI/ML device or a comparative effectiveness study, many of the requested fields (e.g., sample size for test set, data provenance, ground truth experts, adjudication, MRMC study, standalone performance, training set size) are not applicable.

Here's the breakdown based on the provided text's focus on a physical laser device clearance:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Determination)

Acceptance Criteria Category	Specific Criteria (Inferred from 510(k))	Reported Device Performance (Leonardo Duster)
Indications for Use	Identical to predicate device	Identical to predicate device (SOLTIVE™ Laser System) across Urology, Lithotripsy, Gastroenterology, and Gynecology.
Technological Characteristics	Substantially similar to predicate device; no new safety/effectiveness issues.	Similar in display, mode, laser power (60W), laser type (Thulium), wavelength (1940nm), aiming beam (525nm vs. 500-550nm), laser class (4), operation mode (Pulsed, CW), pulse frequency (1-2500 Hz), cooling (air), main power supply (100-240 Vac; 50/60 Hz). Pulse length/duration (0.04-50ms vs. 0.2-50ms) is "nearly identical." Dimensions are "similar." Weight is "slightly heavier" (41kg vs. 33kg), but not considered a safety/effectiveness issue for this type of device.
Safety Testing	Compliance with relevant electrical safety, EMC, laser safety, and usability standards.	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-2-22, IEC 60825-1, and 21 CFR 1040.
Software Validation	Compliance with FDA Guidance: Content of Premarket Submissions for Device Software Functions.	Firmware validated according to FDA Guidance (2023) with "basic level of documentation." Complies with IEC 62366-1.
Biocompatibility	Compliance with ISO 10993 series for cytotoxicity, irritation, hypersensitivity, pyrogenicity, systemic toxicity, leachable substances, and chemical characterization.	Complies with ISO 10993-5, -10, -11, -17, -18, and ISO/TS 21726.
Sterilization	Compliance with ISO 11135, EN ISO 11737-2, and EN 556-1 for reusable and single-patient use fiber optic probes.	Complies with ISO 11135, EN ISO 11737-2, EN 556-1 for both reusable (autoclave) and single-patient use (EO sterilization) probes.
Reprocessing Validation	Validation according to FDA Guidance: Reprocessing Medical Devices in Health Care Settings.	Reprocessing validation performed for reusable fiber optic probes according to FDA Guidance.
Risk Management	Application of risk management to medical devices according to ISO 14971.	Complies with ISO 14971:2019-12.
Labeling/Information	Compliance with EN 1041 and IEC ISO 15223-1.	Complies with EN 1041 and IEC ISO 15223-1.

Study Details Pertaining to the Leonardo Duster 510(k) Clearance

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. This 510(k) clearance is based on non-clinical (bench) testing and comparison to a predicate device, not a performance study on a test set of data (like for an AI/ML device). The "test set" in this context refers to physical devices and components being tested in a lab setting. These tests were conducted by "accredited testing laboratories," but the location is not specified beyond "Bonn, Nordrhein-Westfalen, Germany" for the manufacturer. No patient data is involved in this type of submission.
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 ground truth established by medical experts for a "test set" of patient data was carried out. The "ground truth" for a physical device like this is its adherence to engineering specifications and regulatory performance standards.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No adjudication of expert opinions on medical cases was performed as this is not a clinical or AI performance study.
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. An MRMC study was not done. This is a physical laser surgical instrument, and the clearance is for the device itself, not an AI/ML component assisting human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an algorithm, but a physical medical device. Software validation was performed for the device's firmware, but this does not represent a "standalone algorithm" performance in the context of AI/ML.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- N/A. As this is a physical device, the "ground truth" for its clearance is based on its adherence to engineering specifications, national and international consensus standards for medical devices (e.g., electrical safety, laser safety, biocompatibility, sterilization, usability), and its functional output parameters (e.g., laser power, wavelength, pulse characteristics). There's no clinical "ground truth" like pathology or outcomes data presented for this 510(k) summary, as "Clinical testing was not required to establish substantial equivalence."
The sample size for the training set:
- N/A. No training set was used as this device is a physical laser surgical instrument, not an AI/ML algorithm.
How the ground truth for the training set was established:
- N/A. No training set was used.

Summary

FDA 510(k) Clearance Letter - Leonardo Duster

Page 1

July 14, 2025

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

Re: K250504
Trade/Device Name: Leonardo Duster
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: February 20, 2025
Received: February 20, 2025

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 (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

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K250504 - Daniel Kamm Page 2

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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the

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K250504 - Daniel Kamm Page 3

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/device-advice-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 -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.07.14 14:22:56 -04'00'

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

Page 4

FORM FDA 3881 (8/23) Page 1 of 2 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250504
Device Name: Leonardo Duster

Indications for Use (Describe)

Urology

Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
Laser Resection of the Prostrate (LRP)
Laser Enucleation of the Prostate (LEP)
Laser Ablation of the Prostate (LAP)
Transurethral Incision of the Prostate (TUIP)
Condylomas
Urethral/ureteral structures
Lesions of external genitalia
Bladder neck incisions (BNI)
Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragmentation of renal calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitis
Haemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm Gynecology
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions

Gynecology

Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.

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.

Page 5

FORM FDA 3881 (8/23) Page 2 of 2

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."

Page 6

510(k) Summary: 510(k) Number K250504

CeramOptec GMBH
Siemensstrabe 44
Bonn Nordrhein-Westfalen, Germany D-53121
Telephone +49 228 979670
Date Prepared: July 10, 2025
Contact: Dr. Roland Dreschau, Director
Email Roland.Dreschau@biolitec.com

1) Identification of the Device:

Trade/Device Name: Leonardo® Duster
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

2) Equivalent legally marketed device: K242191 SOLTIVE™ Laser System

Trade/Device Name: SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)
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

3) Reference Devices (Sterile Reusable and Single Patient Use Fiberoptic Probes)

Biolitec Medical Devices, Inc.:
MegaBeam Reusable Fiber Optic Delivery System: K113688
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 Fiber Optic Delivery System with Additional Tips & Handpiece: 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

4) Indications for Use:

Urology

Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]
Laser Resection of the Prostrate (LRP)
Laser Enucleation of the Prostate (LEP)

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Page | 2

Laser Ablation of the Prostate (LAP)
Transurethral Incision of the Prostate (TUIP)
Condylomas
Urethral/ureteral strictures
Lesions of external genitalia
Bladder neck incisions (BNI)
Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors
Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi
Treatment of distal impacted fragments remaining in the ureters following lithotripsy

Lithotripsy and Percutaneous Urinary Lithotripsy Indications

Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones
Endoscopic fragmentation of renal calculi
Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed

Gastroenterology

Open and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:

Appendectomy
Polyps
Biopsy
Gall Bladder calculi
Biliary/Bile duct calculi
Ulcers
Gastric ulcers
Duodenal ulcers
Non Bleeding Ulcers
Pancreatitis
Haemorrhoids
Cholecystectomy
Benign and Malignant Neoplasm Gynecology
Angiodysplasia
Colorectal cancer
Telangiectasias
Telangiectasias of the Osler-Weber-Renu disease
Vascular Malformation
Gastritis
Esophagitis
Esophageal ulcers
Varices
Colitis
Mallory-Weiss tear
Gastric Erosions

Gynecology

Open, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation,

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vaporization, coagulation and hemostasis) of soft tissue.

5) Description of the Device:

6) The comparison between the overall specifications of predicate device and the subject device is shown in Table 1, below.

Table 1 Substantial Equivalence Chart

Characteristic	Olympus Surgical Technologies America K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	CeramOptec GMBH Leonardo® Duster
Indications for Use	The SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE™ Laser Fibers, and Accessories) is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.Urology• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP)• Laser Ablation of the Prostate (LAP)• Transurethral Incision of the Prostate (TUIP)• Condylomas• Urethral/ureteral strictures• Lesions of external genitalia	The Leonardo® Duster is intended for incision, excision, resection, ablation, coagulation, hemostasis, and vaporization of soft tissue, with or without an endoscope, in the following indications: urology, lithotripsy, gastroenterological surgery and gynecological surgery.Urology• Ablation of Benign Prostatic Hyperplasia (Hypertrophy) [BPH]• Laser Resection of the Prostrate (LRP)• Laser Enucleation of the Prostate (LEP)• Laser Ablation of the Prostate (LAP)• Transurethral Incision of the Prostate (TUIP)• Condylomas• Urethral/ureteral strictures• Lesions of external genitalia

Page 9

Page | 4

Characteristic	Olympus Surgical Technologies America K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	CeramOptec GMBH Leonardo® Duster
	• Bladder neck incisions (BNI)• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi•Treatment of distal impacted fragments remaining in the ureters following lithotripsy.Lithotripsy and Percutaneous Urinary Lithotripsy Indications• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones• Endoscopic fragmentation of renal calculi• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.GastroenterologyOpen and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:• Appendectomy• Polyps• Biopsy• Gall Bladder calculi• Biliary/Bile duct calculi• Ulcers• Gastric ulcers• Duodenal ulcers• Non Bleeding Ulcers• Pancreatitis• Haemorrhoids• Cholecystectomy• Benign and Malignant Neoplasm Gynecology•Angiodysplasia• Colorectal cancer• Telangiectasias• Telangiectasias of the Osler-Weber-Renu disease• Vascular Malformation• Gastritis• Esophagitis• Esophageal ulcers• Varices	• Bladder neck incisions (BNI)• Ablation and resection of bladder tumors, urethral tumors, and ureteral tumors• Endoscopic fragmentation of urethral, ureteral, bladder, and renal calculi•Treatment of distal impacted fragments remaining in the ureters following lithotripsy.Lithotripsy and Percutaneous Urinary Lithotripsy Indications• Endoscopic fragmentation of urethral, ureteral, bladder and renal calculi including cystine, calcium oxalate, monohydrate and calcium oxalate dehydrate stones• Endoscopic fragmentation of renal calculi• Treatment of distal impacted fragments of steinstrasse when guide wire cannot be passed.GastroenterologyOpen and endoscopic gastroenterology surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) including:• Appendectomy• Polyps• Biopsy• Gall Bladder calculi• Biliary/Bile duct calculi• Ulcers• Gastric ulcers• Duodenal ulcers• Non Bleeding Ulcers• Pancreatitis• Haemorrhoids• Cholecystectomy• Benign and Malignant Neoplasm Gynecology•Angiodysplasia• Colorectal cancer• Telangiectasias• Telangiectasias of the Osler-Weber-Renu disease• Vascular Malformation• Gastritis• Esophagitis• Esophageal ulcers• Varices

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Characteristic	Olympus Surgical Technologies America K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	CeramOptec GMBH Leonardo® Duster
	• Colitis• Mallory-Weiss tear• Gastric ErosionsGynecologyOpen, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.	• Colitis• Mallory-Weiss tear• Gastric ErosionsGynecologyOpen, endoscopic (including hysteroscopic) and laparoscopic gynecological surgery (incision, excision, resection, ablation, vaporization, coagulation and hemostasis) of soft tissue.IDENTICAL INDICATIONS FOR USE
Photo	[Image of SOLTIVE device]	[Image of Leonardo Duster device]
Display	Touch Screen	Touch Screen SAME
Mode	Fiber laser	Fiber laser SAME
Laser power	60W	60W SAME
Laser type	Thulium Laser	Thulium Laser SAME
Wavelength	1940 nm	1940 nm SAME
Aiming beam	500 - 550 nm,	525 nm SAME
Aiming beam mW	≤ 5 mW	≤ 3mW +/-20%
Laser Class	4	4
Operation mode	Pulsed, Continuous Wave (CW)	Pulsed, Continuous Wave (CW) SAME
Pulse length/duration	0.2 to 50ms	0.04 to 50ms NEARLY IDENTICAL
Pulse frequency	1 to 2500 Hz	1 to 2500 Hz SAME
Cooling	Air cooling system	Air cooling system SAME

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Characteristic	Olympus Surgical Technologies America K242191 SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)	CeramOptec GMBH Leonardo® Duster
Main power Supply	100-240 Vac; 50/60 Hz; 1200 VA	100-240 Vac; 50/60 Hz; 1000 VA SAME
Dimensions of system	25.5 X 37.0 X 56.0 cm	57.7 cm (W) × 36.8 cm (D) × 37.8 cm (H) SIMILAR.
Weight	33kg	41kg SLIGHTLY HEAVIER

7) The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness.

Safety and Effectiveness, comparison to predicate device: The INDICATIONS FOR USE are IDENTICAL. The results of bench and standards testing indicate that the new device is as safe and effective as the predicate device.

8) Summary of non-clinical testing:

Firmware was validated according to the FDA Guidance: Content of Premarket Submissions for Device Software Functions Guidance for Industry and Food and Drug Administration Staff (2023). Software validation documents were provided for a basic level of documentation. Reprocessing validation (for reusable fiber optic probes) was performed according to Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling Guidance for Industry and Food and Drug Administration Staff

This device complies with the applicable portions of the standards listed below:

21 CFR 1040 PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS
EN 1041:2008 Information Supplied By The Manufacturer Of Medical Devices
ISO 14971: 2019-12 Medical devices — Application of risk management to medical devices FDA # 5-125
IEC ISO 15223-1: 2021-07 (Corrected Version 2017-03) Medical devices — Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 1: General requirements FDA # 5-134
IEC 60601-1:2005/AMD2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD) FDA # 19-49
IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests FDA # 19-36
IEC 60601-1-6:2010/AMD2:2020 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability FDA # 5-132

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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 62366-1:2015/AMD1:2020 Medical device software - Software life cycle processes FDA # 5-129
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 following standards were applied to the laser fiber probes:

Biocompatibility:

Cytotoxicity ISO 10993-5:2009
Irritation ISO 10993-10:2013
Delayed type hypersensitivity ISO 10993-10:2013
Material mediated pyrogenicity ISO 10993-11:2018
Acute systemic toxicity ISO 10993-11:2018
Allowable limits for leachable substances ISO 10993-17:2009; ISO/TS 21726:2019
Chemical characterization ISO 10993-18:2020

Sterilization:

ISO 11135:2014 + AMD. 1:2019 for the sterilization process and
EN ISO 11737-2 for the tests of sterility. T
EN 556-1: "Sterilization of medical devices - Requirements for medical devices to be designated "STERILE"- Part 1: Requirements for terminally sterilized medical devices"

The standards testing was conducted by accredited testing laboratories.

9) Summary of clinical testing:

Clinical testing was not required to establish substantial equivalence.

10) Conclusion:

After analyzing bench, software validation, and standards compliance tests, it is the conclusion of CeramOptec GMBH that the new CeramOptec GMBH Leonardo® Duster 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.