The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.

Device Description

The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the SOL Portable Diode Laser Unit, claiming substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. The study described is a comparative performance test against predicate devices.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated for a novel device performance. Instead, the study aims to show that the new device (SOL Portable Diode Laser Unit) performs as well as or better than the predicate devices, and that all devices (subject and predicates) meet a general standard.

Acceptance Criteria (Based on IEC 60601-2-22)	Reported Device Performance (SOL Portable Diode Laser Unit)	Reported Predicate Performance
Laser output should vary from the device's setting by less than ± 20% of the setting.	Average variance:	Average variance:
	- 1.4% in Continuous Wave (CW)	- 2.2% in CW
	- 0.5% in Pulse (P)	- 2.7% in P
Conclusion: The subject device demonstrated less variability (more control) than the cleared predicate devices, satisfying the standard.

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

Sample Size for Test Set: Not explicitly stated. The text mentions "Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings..." This implies a series of measurements across different power settings for both the subject device and two predicate devices, but the exact number of measurements or units tested is not provided.
Data Provenance: The study was conducted for the purpose of a 510(k) submission, implied to be by the manufacturer (Den-Mat Holdings, LLC). The nature of the performance data (e.g., in-house testing) suggests it's prospective, but no specific country of origin for the data is mentioned beyond the manufacturer's location in Lompoc, CA, USA.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This study does not involve expert evaluation for establishing "ground truth" in the clinical sense (e.g., disease diagnosis). It is a technical performance comparison based on physical measurements of laser output.

4. Adjudication Method

Not applicable. There is no adjudication method described as the study is a technical comparison of laser output measurements against a standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an MRMC comparative effectiveness study. It's a technical performance comparison of a medical device against predicate devices, specifically focusing on laser output accuracy.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

While the device (SOL Portable Diode Laser Unit) operates in a standalone manner for laser emission, the performance data presented is for the device itself (its laser output characteristics) rather than an "algorithm only" performance in the context of AI or diagnostic software. Therefore, this question, framed for AI/algorithm performance, is not directly applicable. The performance described is for the hardware's output.

7. The Type of Ground Truth Used

The "ground truth" for this study is the device's setting for laser output power, against which the actual measured output is compared. The acceptance criterion of "less than ± 20% of the setting" from IEC 60601-2-22 serves as the standard or benchmark.

8. The Sample Size for the Training Set

Not applicable. This is not a study involving machine learning or AI where a training set would be used. The performance data is derived from direct measurements of the physical device.

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

Not applicable. As there is no training set, there is no ground truth established for one.

Summary

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JUL 25 2014 SECTION 5

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR §807.92.

Submitter's name, address, telephone number, contact person, and date summary 1. prepared:

Submitter:	Den-Mat Holdings, LLC.1017 West Central Ave.Lompoc, CA 93436, USATel. (805) 346-3700
Contact Person:	Robert Wang, RACRegulatory Affairs ManagerTel.: (805) 346-3700 Ext. 3767(805) 346-3767 DirectFax: (805) 347-7940E-mail: rwang@denmat.com

April 11, 2014 Date Summary Prepared:

Name of device, including the trade name and classification name: 2.
Trade/Proprietary Name: SOL Portable Diode Laser Unit (with wireless foot control)

Common Name: Powered laser surgical instrument

Device Classification Name:	Regulation Number	Class	Product Code
Laser surgical-instrument foruse in general and plasticsurgery and in dermatology.	878.4810	II	GEX

Identification of the predicate device or legally marketed device or devices to which 3. substantial equivalence is being claimed:

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K141838 Page 2 of 4 SOL Portable Diode Laser Unit (with wireless foot control) Traditional 510 (k) Premarket Notification

Submitter: DenMat Holdings, LLC

Den-Mat Holdings, LLC Company: Sapphire ST Portable Diode Laser Device: 510(k): K103667 Date Cleared: December 29, 2010 Company: Discus Dental, LLC Device: ST3 K102639 510(k): December 01, 2010 Date Cleared:

A description of the device that is the subject of the 510(k), including an explanation of 4. how the device functions, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):

The SOL Portable Diode Laser Unit (with wireless foot control) has the same intended use and indications for use as the Sapphire Portable Diode Laser (K103667). It is an alternate construction, incorporating the same principles of operation in a more ergonomic industrial design package. The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.

ડ. Statement of intended use:

The SOL Portable Diode Laser Unit (with wireless foot control) is a medical electrical device intended for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, vaporizing and coagulation of soft tissues using a fiber optic delivery system.

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Statement of how the technological characteristics of the device compare to those of 6. the predicate or legally marketed device:

The proposed SOL Portable Diode Laser Unit (with wireless foot control) has the following technological similarities to the predicate devices:

the equivalent working beam wavelength, ●
the equivalent pulse control digital emission control, .
the same laser source solid state diode, .
. the equivalent user interface, and
the equivalent wireless foot control .

Statement of how the functional characteristics of the device compare to those of 7. the predicate or legally marketed device:

The proposed SOL Portable Diode Laser Unit (with wireless foot control) has the following functional similarities to the predicate devices:

. the equivalent indications for use,
the same operating principle, .
. the same basic construction,
the same shelf life, and .
the same packaging materials and processes. .

Comparative Performance Data: 8.

The SOL Portable Diode Laser Unit (with wireless foot control) has been tested side-by-side against two of the predicate devices. Measurements of the output of the subject devices' working beam range from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the unit's settings by an average of only 1.4% in CW and 0.5% in P compared to the predicate's variance of 2.2% in CW and 2.7% in P. The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device's setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard, with the subject device demonstrating less variability (more control) than the cleared predicate devices.

Page 3 of 4

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9.	Technological Characteristics
----	-------------------------------

Device Name	SOL Portable DiodeLaser Unit (withwireless foot control)(Subject Device)	Sapphire ST PortableDiode Laser(Predicate Device)	SL3.(Predicate Device)
Manufacturer	DenMat Holding, LLC	DenMat Holding, LLC	Discus Dental, LLC
510(k)Number	KXXXXXXX	K103667	K102639
Wavelength	$808 \pm 5$ nm	$808 \pm 5$ nm	$808 \pm 10$ nm
Power	3 Watts	3 Watts	3 Watts
Aiming Bean	$405 \pm 10$ nm,max. 5 mW	$640 \pm 10$ nm,max. 2 mW	650 nm,max. 5 mW
CoolingSystem	Convection cooled	Convection cooled	Convection cooled
Pulse Control	Digital emission control	Digital emission control	Unknown
Laser Source	Solid-state diode	Solid-state diode	Solid-state diode
PowerRequirements	24W 5VDC supplied from110-120 VCA @ 60 Hz or220–240 VAC @ 50 Hz(switchable)	24W 5VDC supplied from110-120 VCA @ 60 Hz or220–240 VAC @ 50 Hz(switchable)	100 - 240 VAC,50 - 60 Hz
UserInterface	Membrane touch pad,LCD Display, LEDIndicators	Membrane touch pad,LCD Display, LEDIndicators	LCD Touch screen
FiberopticTip	Disposable,400 umUnit dose	Disposable,400 umUnit dose	Unknown

10. Conclusions:

The SOL Portable Diode Laser Unit (with wireless foot control) has the equivalent indications for use and technological characteristics as that of the predicate devices. The minor technological and material differences exist between the SOL Portable Diode Laser Unit (with wireless foot control) and its predicate devices raise no new questions of safety or effectiveness. Performance data demonstrate that the SOL Portable Diode Laser Unit (with wireless foot control) is as safe, as effective, and performs as well as or better than the DenMat, Sapphire ST Portable Diode Laser (K103667) and Discus Dental, SL3 (K102639). Therefore, it can be concluded that the SOL Portable Diode Laser Unit (with wireless foot control) is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - USA

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2014

Den-Mat Holdings, LLC Mr. Robert Wang, RAC Regulatory Affairs Manager 1017 West Central Avenue Lompac. California 93436

Rc: K141838

Trade/Device Name: SOL Portable Diode Laser Unit (with wireless foot control) 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: July 8, 2014 Received: July 10, 2014

Dear Mr. Wang:

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. 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 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

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Page 2 - Mr. Robert Wang, RAC

device-related adverse events} (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

David= David= S

· Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K141838

Device Name

SOL Portable Diode Laser Unit (with wireless foot control)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

SHEN STERN CONTROL THOR FOR FOR FOR FOR FOR CONSTITUTION OF THE CONSTITUTION OF

nourence of Center for Devices and Radiological Health (CDRH) (Signature)

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."

For BSA

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."

FORM FDA 3881 (1/14)

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.