The SL3™ is intended to be used for oral soft tissue surgery, including: biopsies, hemostatic assistance; treatment of apthous ulcers; frenectomy; gingival incision and excision; gingivectomy; gingivoplasty; incising and draining of abscesses; operculectomy; removal of fibromas; soft-tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket) and tissue retraction for impressions.

The SL3 laser is to provide the ability to perform intraoral soft tissue dental, general, oral maxilla-facial and cosmetic surgery. The SL3 laser is intended for ablating, incising, vaporizing and coagulation of soft tissues using a contact fiber optic delivery system.

The device will be used in the following areas: general and cosmetic dentistry, otolaryngology, arthroscopy, gastroenterology, general surgery, dermatology & plastic surgery, genecology, urology, opthamology and pulmonary surgery. The following are the oralpharngeal indications for use for which the device will be marketed:

-Excision and Incision Biopsies
-Hemostatic assistance
-Treatment of Apthous Ulcers
-Frenectomy
-Frenotomy
-Gingival Incision and Excision
-Gingivectomy
-Gingivoplasty
-Incising and Draining of 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
-Light activation of bleaching materials for teeth whitening
-Laser-assisted bleaching/whitening of teeth

Device Description

The SL3™ is a Class IV soft-tissue diode laser that can be used for a wide variety of soft-tissue procedures. This device uses a Gallium, Aluminum, Arsenic (GaAIAS) diode for the active medium, producing laser energy at 810 nanometer wavelength. Laser technology has been steadily evolving, allowing doctors to provide less invasive treatment for many dental procedures, both preventative and restorative. The SL3™ is designed to be compact, portable, reliable and user friendly. It provides the practitioner with a versatile instrument for applications ranging from excisions to vaporization of tissues. The diode laser energy is delivered through optical fiber in the hand piece to the removable fiber tips. The system may be utilized for a wide variety of surgical and cosmetic procedures.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a medical device called SL3, a surgical laser system. It focuses on establishing substantial equivalence to previously cleared devices rather than primarily presenting a study to prove performance against acceptance criteria in the traditional sense of a clinical trial for diagnostic accuracy or treatment efficacy.

Therefore, many of the requested categories for a study proving device performance (like sample sizes for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or not explicitly detailed in this type of regulatory submission.

The acceptance criteria here are implicitly related to the technical specifications and safety profile being substantially equivalent to the predicate devices. The "study" proving this is essentially the comparison table and the demonstration that the SL3 meets similar performance characteristics and safety standards as the predicate devices.

Here's the information parsed from the document based on your request, with explanations for what is not applicable to this type of submission:

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

For a 510(k) submission, "acceptance criteria" are not typically formal performance metrics in the way they would be for a diagnostic AI study. Instead, they are implicit in the substantial equivalence comparison - meaning the new device must perform comparably to the predicate devices and meet relevant safety and essential performance standards. The "reported device performance" is largely represented by its technical specifications.

Acceptance Criteria (Implied by Predicate Comparison)	Reported Device Performance (SL3)
Type of laser: Diode laser	Diode laser
Wavelength: ~808 nm	$808 \pm 10$ nm
Max output power: Comparable to predicates (2.0W - 2.5W)	3.0 Watt
Power requirements: Standard for medical devices	100-240 VAC, @ 50-60 Hz, 1A
Battery operation option: Comparable to predicate with battery	Corded or battery operation
Operation mode: Continuous wave and pulsed	Continuous wave and pulsed
Delivery system: 400 µm core quartz fiber	400 µm core quartz fiber
Fiber connection: FC connector to handpiece with disposable tip	FC connector to handpiece - Disposable tip magnetically attached to handpiece
Aiming beam: 5 mW diode laser, 650 nm	5 mW diode laser, 650 nm
Activation means: Wireless foot switch	Wireless foot switch - takes 2 AA batteries
Interface: Color LCD touch-screen GUI with pre-set procedures or manual control	Color LCD touch-screen GUI on desk unit displays 8 pre-set procedures or manual control to set power and laser mode (continuous or pulse)
Diode Assembly: 2.0 - 2.5 watt single emitter diode	3 watt single emitter diode lasing at 808 nm
Cooling system: Heat sink or fan	Heat sink
Laser diode power supply: External or internal	External
Intended Use / Indications for Use: Same as predicates	Matches and potentially expands slightly (implicit in higher power) what is listed for predicates. All listed indications are covered.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: This is a 510(k) pre-market notification for a laser device, not an AI or diagnostic device requiring a "test set" in the context of clinical performance data. The submission relies on technical comparisons and safety data, not a patient-level data set.

3. 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)

Not Applicable: No "test set" or "ground truth" in this context as described for diagnostic or AI systems. The "ground truth" for a laser device would relate to engineering specifications, safety standards, and pre-clinical testing, which are performed by engineers and regulatory experts, not typically by medical experts establishing diagnostic ground truth from patient data.

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

Not Applicable: No test set requiring annotation adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This is a surgical laser device; MRMC studies are used for diagnostic imaging systems, not for comparing human performance with and without a surgical instrument like a laser.

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

Not Applicable: This device is a surgical instrument intended for human operation, not a standalone algorithm.

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

Type of Ground Truth: For this device, the "ground truth" is primarily based on engineering specifications, recognized national and international safety standards (e.g., laser safety standards), and the established performance and safety profiles of the predicate devices. Compliance with these technical and safety standards, along with successful pre-clinical testing (which would include electrical safety, EMC, laser emission measurements, etc.), forms the basis of "proof." There is no patient-level "ground truth" in the diagnostic sense.

8. The sample size for the training set

Not Applicable: No "training set" as this is not an AI or machine learning device. Device development involves engineering design, prototyping, and testing, not data-driven training.

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

Not Applicable: No training set.

Summary

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510(k) Summary

DEC 1 2010

1. Contact Person:
  Clark D. vonAhsen Regulatory Affairs Discus Dental, LLC 8550 Higuera Street · Culver City, CA 90232 310.845.8216 - phone 310.845.8647 - fax clarkv@discusdental.com

Date of Summary Preparation: 11/30/2010

Name of Medical Device: 2.

Proprietary Name:	SL3
Common/Usual Name:	Surgical Laser System
Classification Name:	Laser, Surgical (21 CFR 878.4810 Product Code GEX)

3. Substantial Equivalence:

The SL3 is substantially equivalent to the following commercially marketed product

Predicate Device	Company	510(k) No.
SoftLase Pro	Zap Lasers, LLC	K091796
Styla	Zap Lasers, LLC	K081214

4. Description of Device:

{1}------------------------------------------------

5. Intended Use

6. Summary of Technological Characteristics

	Discus Dental, LLC	Zap Laser, LLC	Zap Laser, LLC
Name	---	---	---
	SL3	Softlase Pro	Styla
510(k) number	K102639	K091796	K081214
Type of laser	Diode laser	Diode laser	Diode laser
Wavelength	$808 \pm 10$ nm	$808 \pm 5$ nm	$808 \pm 5$ nm
Max outputpower	3.0 Watt	2.0 Watt	2.0 Watt
Powerrequirements	100-240 VAC, @ 50-60Hz, 1A	100-240 VAC, @ 50-60Hz, 1A	90-240 VAC @ 50-60 Hz,0.8A
Battery	Corded or batteryoperation	Corded - no battery	Battery operated
Operation mode	Continuous wave andpulsed	Continuous wave andpulsed	Continuous wave andpulsed
Delivery system	400 um core quartz fiber	400 um core quartz fiber	400 um core quartz fiber
Fiber	FC connector tohandpiece - Disposable tipmagnetically attached tohandpiece	SMA 905 connector tohandpiece - perpetualfiber	Disposable tipmagnetically attached tohandpiece
Fiber aimingbeam	5 mw diode laser, 650 nm	5 mw diode laser, 650 nm	5 mw diode laser, 650 nm
Activation means	Wireless foot switch -takes 2 AA batteries	Corded foot switch	Wireless foot switch -takes 2 AA batteries
Interface	Color LCD touch-screenGUI on desk unit displays8 pre-set procedures ormanual control to setpower and laser mode(continuous or pulse)	Color LCD touch-screenGUI on desk unit displays8 pre-set procedures ormanual control to setpower and laser mode(continuous or pulse)	OLED on handpiecedisplays 8 pre-setprocedures or manualcontrol to set power andlaser mode (continuous orpulse)
Diode Assembly	3 watt single emitterdiode lasing at 808 nm	2.5 watt single emitterdiode lasing at 808 nm	2.0 watt single emitterdiode lasing at 808 nm
Cooling system	Heat sink	Fan	Heat sink
Laser diodepower supply	External	Internal	External
Intended Use /	-Excision and Incision	-Excision and Incision	-Excision and Incision
Indications for	Biopsies	Biopsies	Biopsies
Use	-Hemostatic assistance	-Hemostatic assistance	-Hemostatic assistance
	-Treatment of ApthousUlcers	-Treatment of ApthousUlcers	-Treatment of ApthousUlcers
	-Frenectomy	-Frenectomy	-Frenectomy
	-Frenotomy	-Frenotomy	-Frenotomy
	-Gingival Incision andExcision	-Gingival Incision andExcision	-Gingival Incision andExcision
	-Gingivectomy	-Gingivectomy	-Gingivectomy
	-Gingivoplasty	-Gingivoplasty	-Gingivoplasty
	-Incising and Draining ofAbscesses	-Incising and Draining ofAbscesses	-Incising and Draining ofAbscesses
	-Operculectomy	-Operculectomy	-Operculectomy

{2}------------------------------------------------

{3}------------------------------------------------

-Oral Papillectomy	-Oral Papillectomy	-Oral Papillectomy
-Removal of Fibromas	-Removal of Fibromas	-Removal of Fibromas
-Exposure of unerupted	-Exposure of unerupted	-Exposure of unerupted
teeth	teeth	teeth
-Soft Tissue Crown	-Soft Tissue Crown	-Soft Tissue Crown
Lengthening	Lengthening	Lengthening
-Sulcular Debridement	-Sulcular Debridement	-Sulcular Debridement
(removal of diseased or	(removal of diseased or	(removal of diseased or
inflamed soft tissue in the	inflamed soft tissue in the	inflamed soft tissue in the
periodontal pocket)	periodontal pocket)	periodontal pocket)
-Tissue retraction for	-Tissue retraction for	-Tissue retraction for
Impression	Impression	Impression
-Vestibuloplasty	-Vestibuloplasty	-Vestibuloplasty
-Light activation of	-Light activation of	-Light activation of
bleaching materials for	bleaching materials for	bleaching materials for
teeth whitening	teeth whitening	teeth whitening
-Laser-assisted bleaching /	-Laser-assisted bleaching /	-Laser-assisted bleaching /
whitening of teeth	whitening of teeth	whitening of teeth

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

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

1 2010 DEC

Discus Dental, LLC % Mr. Clark D. vonAhsen Regulatory Affairs 8550 Higuera Street Culver City, California 90232

Re: K102639

Trade/Device Name: SL3 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: November 18, 2010 Received: November 24, 2010

Dear Mr. vonAhsen:

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.

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Page 2 – Mr. Clark D. vonAhsen

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 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark N. Molkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

(Part 21 CFR 801 Subpart D)

Device Name: ਨ। ਤ

Indications for Use:

-Excision and Incision Biopsies -Hemostatic assistance -Treatment of Apthous Ulcers -Frenectomy -Frenotomy -Gingival Incision and Excision -Gingivectomy -Gingivoplasty -Incising and Draining of 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 -Light activation of bleaching materials for teeth whitening -Laser-assisted bleaching/whitening of teeth Over-The-Counter Use Prescription Use OR (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K102639

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.