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

Device Description

PenLase is a surgical equipment, simple tool, portable, and easy to use. It is a tool that can be used for the treatment of oral soft tissue surgery, plastic surgery.

The PenLase utilizes a semiconductor diode which consists of semiconductor "chips" made from Aluminum, Gallium and Arsenide, together commonly referred to as AlGaAs , with invisible infrared radiation as a laser source. The laser power is delivered to the treatment area via a fiber tip. The disposable fiber tips are bendable in a variety of angle for maximum access to all areas of the mouth.

PenLase delivers 0.7 Watts and 1.7 Watts with wavelength 810±10 nm of continue laser power without cords, outlets or foot switches, which makes its battery life last longer.

The PenLase charging station recharges up to two PenLase batteries simultaneously, a fully charged battery can last for several patients or procedures.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called "PenLase Dental Laser Therapy System." This submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, device performance numbers, clinical study details, and ground truth establishment is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the input:

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

Not Available. The document does not specify quantitative acceptance criteria for device performance or report specific performance metrics for the PenLase system in a clinical context. The submission focuses on substantial equivalence through non-clinical bench tests and comparison of specifications to predicate devices.

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 Available. The "Non-Clinical Test Conclusion" section (Section 7) states that "Bench tests were conducted to verify that the proposed device met all design specifications." These are technical, non-clinical tests (e.g., electrical safety, electromagnetic compatibility, biocompatibility), not clinical studies with patient test sets. Therefore, there's no sample size of patients or data provenance information of this type.

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 / Not Available. As no clinical "test set" in the sense of patient data is described, there is no information about experts establishing ground truth for such a set.

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

Not Applicable / Not Available. There is no clinical test set described, so no adjudication method is mentioned.

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

No. No MRMC comparative effectiveness study was done or mentioned. This device is a laser therapy system, not an AI-assisted diagnostic tool.

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

Not Applicable. This device is a physical laser therapy tool, not an algorithm. Standalone performance as an algorithm is not relevant.

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

Not Applicable / Not Available. For the non-clinical tests conducted, the "ground truth" would be established by relevant engineering and safety standards (e.g., IEC and ISO standards mentioned), which ensure the device adheres to safety and functional specifications. There is no biological "ground truth" in the context of clinical outcomes or pathology mentioned in this submission.

8. The sample size for the training set

Not Applicable / Not Available. There is no "training set" in the context of machine learning or AI mentioned for this device. The development process relies on design specifications and adherence to predicate device characteristics.

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

Not Applicable / Not Available. As there is no training set described, the method for establishing its ground truth is not applicable.

Summary

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NOV 16 2011

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page ① of ⑤

Premarket Notification 5 10(k) Submission

Section III 510(k) Summary

Project #: M0222011Bd

Section III 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) Number:

l. Date of Submission: 8/24/2011
1. Sponsor

China Daheng Group, Inc. PO Box 8618, #A9 Shangdi Xinxilu Haidian District, Beijing 100085, China Contact Person: Jianli Song Position: Vice general manager Establishment number: 3008705657 Tel: 010-82782668 - 300 Fax: 010-72782669 Email: songjnli@cdhcorp.com.cn

1. Submission Correspondent Mr. Tarzan Wang Mid-Link Consulting Co., Ltd P.O. Box 237-023 Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: tarzan.wang@mid-link.net

Proposed Device Identification

Proposed Device Name: Dental Laser Therapy System Proposed Device Model: penlase Classification: 2 Product Code: GEX Regulation Number: 21 CFR 878.4810 Review Panel: 878 General and Plastic Surgery

Indication for use Statement:

The PenLase is indicated for incision, excision, hemostasis; coagulation and vaporization of soft

III-1

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K1132/2

page (2) of (5)

Premarket Notification 510(k) Submission

Project #: M0222011Bd

tissue including the following indications:

. Excision and Incision Biopsies
0 Hemostatic assistance
0 Treatment of Apthous Ulcers
o Frenectomy
. Frenotomy
. Gingival Incision and Excision
0 Gingivectomy
. Gingivoplasty
0 Incising and Draining of Abscesses
� Operculectomy
o Oral Papillectomy
� Removal of Fibromas
o Soft Tissue Crown Lengthening
. Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
. Tissue retraction for Impression
0 Vestibuloplasty

5. Predicate Device Identification

510(k) Number: K081214 Product Name: Styla microlaser / Styla Ortho Manufacturer: Zap Lasers, LLC

510(k) Number: K093852 Product Name: iLase Manufacturer: Biolase Technology, Inc.

1. Device Description
  PenLase is a surgical equipment, simple tool, portable, and easy to use. It is a tool that can be used for the treatment of oral soft tissue surgery, plastic surgery.

PenLase delivers 0.7 Watts and 1.7 Watts with wavelength 810±10 nm of continue laser power without cords, outlets or foot switches, which makes its battery life last longer.

. ·

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ge of 5

Project #: M0222011Bd

The PenLase charging station recharges up to two PenLase batteries simultaneously, a fully charged battery can last for several patients or procedures.

The PenLase is generally indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

Excision and Incision Biopsies �
. Hemostatic assistance
� Treatment of Apthous Ulcers
o Frenectomy
0 Frenotomy
. Gingival Incision and Excision
� Gingivectomy
0 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

Clinical Application:

Excision and Incision Biopsies	1.7W
Hemostatic assistance	0.7W
Treatment of Apthous Ulcers	0.7W
Frenectomy	1.7W
Frenotomy	1.7W
Gingival Incision and Excision	1.7W
Gingivectomy	1.7W
Gingivoplasty	1.7W
Incising and Draining of Abscesses	1.7W
Operculectomy	1.7W
Oral Papillectomy	1.7W
Removal of Fibromas	1.7W
Soft Tissue Crown Lengthening	1.7W
Sulcular Debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)	0.7W
Tissue retraction for Impression	1.7W
Vestibuloplasty	1.7W

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K113212

Page 4 of 5

Premarket Notification 510(k) Submission

Accessories list:

Project #: M0222011Bd

Accessories	Quantity
PenLase Main Handpiece	1
Charging Station, Power adapter	1
Laser Protective glasses	1
Patient goggle	1
Batteries	2pcs
Disposable Fiber tips(400um)	6pcs
OPERATION MANUAL	1
Laser warning sign	1
Quick Start Guide	1

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification, requirements.

IEC 60601-2-22: 1995, Medical Electrical Equipment – Part 2: Particular requirements for the safety of diagnostic and therapeutic laser equipment.

IEC 60601-1:1988+A1:1991+A2:1995, Medical Electrical Equipment - Part1: General requirements for safety.

IEC 60601-1-2:2007, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests (Edition 3).

ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.

ISO 10993-10: 2002/Amd.1:2006, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity.

8. Substantially Equivalent Conclusion

The proposed device, Dental Laser Therapy System, is determined to be Substantially Equivalent (SE) to the predicate device, Styla microlaser / Styla Ortho (K081214) and iLase (K093852), in respect of safety and effectiveness.

Analysis 1: The output power of proposed device is between that of the two predicates devices, and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device.

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Project #: M0222011Bd

III-5

Analysis 2: the class of the aiming beam of proposed device is lower than that of the iLase, which means the proposed device has lower hazards. And all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device.

Analysis 3: the Fiber tip diameter, beam diameter, spot size of proposed device are similar to that of the Styla Microlaser / Styla Ortho and iLase, and all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device.

Analysis4: the button switch and foot switch are both intended to provide the handpiece on/off capabilities. And all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device.

Analysis5: the dimension of the three devices does not affect the effectiveness of laser. And all of them comply with IEC 60825-1 and IEC 60601-2-22. So the difference will not affect the safety and effectiveness of the proposed device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized, curved lines.

Public Health Service

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

NOV 1 6 2011

China Daheng Group, Inc. % Underwriters Laboratories, Inc. Mr. Jeffrey D. Rongero 12 Laboratory Drive Research Triangle, North Carolina 27709

Re: K113212

Trade/Device Name: Dental Laser Therapy System 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: October 31, 2011

Received: November 01, 2011

Dear Mr. Rongero:

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. Jeffrey D. Rongero

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 (OS) 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. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K1/32/2

Premarket Notification 510(k) Submission Section II Indications for Use Project #:M022201IBd

Section II Indications for Use

510(k) Number: Device Name: Dental Laser Therapy System

Indications for Use:

The PenLase is indicated for incision, excision, hemostasis, coagulation and vaporization of soft tissue including the following indications:

� 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

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D) OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

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

(Division Signoffice of CDRH, Office of Device Evaluation (ODE)
-----------------------------------------------------------------

Division of Surgical, Orthopedic,
and Restorative Devices

Page 1 of 1

510(k) Number K113212

II-1

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.