(15 days)
Not Found
No
The device description focuses on the laser technology and its physical characteristics, with no mention of AI or ML. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is described as a "surgical equipment" and its "Intended Use / Indications for Use" lists various medical procedures such as "Excision and Incision Biopsies", "Hemostatic assistance", and "Treatment of Apthous Ulcers", all of which are therapeutic interventions. Additionally, the performance studies mention "therapeutic laser equipment," further confirming its therapeutic nature.
No
Explanation: The device description and intended uses clearly state that the PenLase is a surgical tool used for incision, excision, hemostasis, coagulation, and vaporization of soft tissue. These are therapeutic actions, not diagnostic ones. The performance studies also refer to "therapeutic laser equipment."
No
The device description clearly outlines hardware components including a semiconductor diode, fiber tip, and charging station, indicating it is not software-only.
Based on the provided information, the PenLase is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes surgical procedures performed directly on soft tissue within the oral cavity (incision, excision, hemostasis, coagulation, vaporization). This is a therapeutic and surgical function, not a diagnostic one performed on samples outside the body.
- Device Description: The description details a surgical equipment utilizing a laser for tissue manipulation. This aligns with a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or providing diagnostic information based on such analysis. The device's function is to physically interact with and alter tissue.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The PenLase's function falls outside this definition.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
GEX
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue (oral soft tissue)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
NOV 16 2011
13212
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
-
- 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
-
- 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
1
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.
-
- 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.
- Device Description
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.
. ·
2
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 |
3
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.
III-4
4
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.
5
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.
6
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
7
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