The stLase with surgical laser operation (Automatic Power Control) that can be used in contact or non-contact technique, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).

The stLase with surgical laser operation that can be used in contact or non-contact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and

The stLase with dental laser operation is intended to be used in contact or non-contact technique for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasty, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, treatment of aphthous ulcers, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), pulpotomy, pulpotomy as an adjunct to root canal therapy, and light activation of bleaching materials for teeth whitening.

Device Description

The Dental Photonics stLase is a soft tissue surgical laser system indicated for use in dental applications. It can generate up to 25 W at 980 nm wavelength in fiberoptic output used for a variety of dental and oral surgical applications, including cutting and coagulation of intraoral and extraoral soft tissues.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the Dental Photonics stLase, a soft tissue surgical laser system. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not specify formal acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) for the device's function. Instead, the "acceptance criteria" presented here is based on demonstration of substantial equivalence to a predicate device. The performance is reported by showing that the technical specifications of the current device are identical to the predicate device.

Specification	Acceptance Criteria (Predicate Device K094049)	Reported Device Performance (stLase K111689)	Meets Criteria?
Wavelength	980 nm	980 nm	Yes
Output power	25 W	25 W	Yes
Power range	0.5-25 W	0.5-25 W	Yes
Increments	0.1-0.5 W	0.1-0.5 W	Yes
Operating modes	Pulsed or CW	Pulsed or CW	Yes
Pulse duration	0.025 ms to 3 ms	0.025 ms to 3 ms	Yes
Timer duration	50 ms to 99.9 s	50 ms to 99.9 s	Yes
Frequency	20,000 Hz	20,000 Hz	Yes
Aiming beam	650 nm, 5mW	650 nm, 5mW	Yes
Cooling	Air cooled, closed control water circuit	Air cooled, closed control water circuit	Yes
Weight	~ 1.8 kg (4 lbs)	~ 1.8 kg (4 lbs)	Yes
Dimensions	14"x14.2"x11"	14"x14.2"x11"	Yes
Power requirements	120V/60Hz or 240V/50Hz	120V/60Hz or 240V/50Hz	Yes
Sterilization method	Steam autoclave	Steam autoclave	Yes

The study that proves the device meets "acceptance criteria" (in this context, substantial equivalence) is the technical comparison and bench testing to demonstrate that the new stLase (K111689) has the "same material design, mechanism of action, technical specifications and function" as the predicate device (stLase K094049).

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

The document exclusively relies on a comparison of technical specifications and bench testing. There is no test set of patient data, clinical data, or imaging data mentioned for evaluating the device's performance in terms of diagnostic or therapeutic outcomes. The provenance of the data is a comparison of published specifications of two laser devices, presumably from internal company documentation and previous 510(k) submissions. This is not retrospective or prospective patient data.

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

Not applicable. There is no test set with patient data requiring expert-established ground truth. The "ground truth" for the technical specifications are the validated specifications of the predicate device, which would have been established through engineering and performance testing at the time of its initial clearance (K094049).

4. Adjudication Method for the Test Set:

Not applicable, as there is no test set of patient data.

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

No, an MRMC comparative effectiveness study was not done. This device is a surgical laser, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.

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

Not applicable. This device is not an AI algorithm. It is a surgical laser that requires human operation. The performance assessment is based on its physical characteristics and functionality, not an AI algorithm's standalone performance.

7. The Type of Ground Truth Used:

The "ground truth" used for demonstrating substantial equivalence is the technical specifications and established performance characteristics of the predicate device (K094049) as determined by engineering validation and previous regulatory clearance. This is not pathology, outcomes data, or expert consensus on clinical cases.

8. The Sample Size for the Training Set:

Not applicable. This device does not involve a training set as it is not an AI/machine learning device.

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

Not applicable, as there is no training set for an AI/machine learning algorithm.

Summary

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FEB 1 6 2012

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

As required by section 807.92(c)

1. SUBMITTER'S INFORMATION

Company Name and Address Dental Photonics, Inc. 1600 Boston-Providence Hwy Walpole, MA 02081 Phone: 781-754-7900

Official Contact Marcy Moore MMP Medical Associates, LLC 16 Appleton St. Waltham, MA 02453 Phone: 919-363-2432

Date Prepared January 24, 2012

2. DEVICE INFORMATION

Trade/Proprietary Name stLase

Common/Usual Name Dental Laser LASER INSTRUMENT, SURGICAL, POWERED Classification Name

(21 CFR 878.4810) Class II

Product Code GEX

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3. PREDICATE DEVICE

Dental Photonics, Inc. K094049 - stLase

4. INTENDED USE

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K111689 p. 3 of 3

5. DEVICE DESCRIPTION

6. SUBSTANTIAL EQUIVALENCE

Substantial equivalence of the stLase is demonstrated by similarity in technical specifications to the predicate device. The stLase has the same material design, mechanism of action, technical specifications and function as the predicate device: stLase Laser K094049. Bench testing and conformity to applicable standards has also been demonstrated.

Both devices are available in continuous wave or pulsed mode and may be used in contact or non-contact mode. Both devices employ a fiber delivery system consisting of a fiber optic connector, cable, handpiece and disposable adapters to hold fiber in the distal part. As can be seen in the comparison table below, there are no technical differences between the current stLase submission and the predicate stLase device.

Specification	Dental Photonics, Inc. stLase	Dental Photonics, Inc. stLase
K Number	K111689	K094049
Wavelength	980 nm	980 nm
Output power	25 W	25 W
Power range	0.5-25 W	0.5-25 W
Increments	0.1-0.5 W	0.1-0.5 W
Operating modes	Pulsed or CW	Pulsed or CW
Pulse duration	0.025 ms to 3 ms	0.025 ms to 3 ms
Timer duration	50 ms to 99.9 s	50 ms to 99.9 s
Frequency	20, 000 Hz	20,000 Hz
Aiming beam	650 nm, 5mW	650 nm, 5mW
Cooling	Air cooled, closed controlwater circuit	Air cooled, closed controlwater circuit
Weight	~ 1.8 kg (4 lbs)	~ 1.8 kg (4 lbs)
Dimensions	14"x14.2"x11"	14"x14.2"x11"
Powerrequirements	120V/60Hz or 240V/50Hz	120V/60Hz or 240V/50Hz
Sterilizationmethod	Steam autoclave	Steam autoclave

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol on the right side. To the left of the bird symbol, the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

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

FEB 1 6 2012

Dental Photonics, Inc. % MMP Medical Associates, LLC Ms. Marcy Moore 16 Appleton Street Waltham, Massachusetts 02453

Re: K111689

Trade/Device Name: stLase 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 08, 2012 Received: February 09, 2012

Dear Ms. Moore:

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 - Ms. Marcy Moore

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.

Ernst Keitl

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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KII1689 p. 10f1

INDICATIONS FOR USE

510(k) Number: K111689

Device Name: stLase

Indications for Use:

The stLase with surgical laser operation that can be used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue, and

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------(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

: $10(k) Number

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.