Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser device for dental and pain relief applications and does not mention any AI or ML components in its description, intended use, or performance studies.

Therapeutic

Yes
The device is used for a variety of dental procedures including those that treat conditions, relieve pain, and improve bodily function, which are all characteristics of therapeutic devices. This is also explicitly stated in the "PAIN INDICATIONS" section and the "Summary of Performance Studies" that call it a "therapeutic heating device".

Diagnostic

No

The device description and indications for use clearly state that this is a therapeutic laser used for incision, excision, vaporization, ablation, and other treatments related to oral soft tissues, tooth whitening, and pain relief. It does not mention any diagnostic capabilities.

SaMD (Software as a Medical Device)

No

The device description explicitly states it uses a solid state diode to emit infrared laser energy transmitted via a fiber optic cable to a handpiece, and includes a base console, delivery system, tips, and a wireless footswitch. These are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
Device Function: The description clearly states that this device is a soft tissue dental laser used for various procedures directly on the patient's oral tissues, teeth, and for pain relief. It emits laser energy to the target site within the body.
Lack of Specimen Analysis: There is no mention of collecting or analyzing any specimens from the patient. The device interacts directly with the patient's body.

Therefore, this device falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. DENTAL SOFT TISSUE INDICATIONS

The indications are identical to the previously cleared predicate systems.

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental givgival and epithelial lining of free gingival and the following specific indications:

· Exposure of Unerupted teeth
· Fibroma removal
· Frenectomy
· Gingival Troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Hemostasis and coagulation
· Gingival incision and excision hemostasis
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Gingival bleeding index
· Excisional and incisional biopsies
· Treatment of aphthous ulcer canker sores and herpetic.
· Vestibuloplasty
1. LASER PERIODONTAL INDICATIONS:

· Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility )

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

1. TOOTH WHITENING INDICATIONS
· Laser Assisted whitening/bleaching of teeth.
· Light activation for bleaching materials for teeth whitening.

4. PAIN INDICATIONS:

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

The Zolar Technology & MFG Co. Inc. Soft Tissue Dental Laser PHOTON/PHOTON PLUS uses a solid state diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to the hand piece that emits the energy to the target site. A visible light (aiming beam) is emitted at the same time to visually assist in identifying the specific treatment location. The Photon/Photon Plus Laser Systems are comprised of a base consol, a detechable delivery system, tips and a wireless footswitch. The Photon/Photon Plus laser is intended to be used by dentist for a variety of oral soft tissue procedures

The original Operator Manual has been revised to reference the additional Pain Indication for use.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral soft tissues, periodontal pocket

Indicated Patient Age Range

Not Found

Intended User / Care Setting

dentist

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)

The subject devices have been tested for thermal, electrical and mechanical safety, as demonstrated in the previously approved clearance 510(k) 122020 and conform to applicable medical device safety standards, IEC 60825-1 and IEC 60601-2-22.

The clinical test for the therapeutic heating device indications listed in item 6 of the IFU have been conducted with human subjects and the performance data table demonstrates that the device can increase the skin temperature to 40 – 45 "c and maintain the effect for at least 10 minutes safely and effectively.

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.

K122020, K121286, K123443

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

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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Public Health Service

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

December 12, 2016

Zolar Technology & Mfg Co. Inc. Paul Atkins Executive Officer 6315 Shawson Drive Mississauga, L5T 1J2 CA

Re: K162114

Trade/Device Name: Photon, Photon Plus 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 17, 2016 Received: November 17, 2016

Dear Paul Atkins:

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 device

1

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" (21 CFR 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. 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) 162114

Device Name Photon, Photon Plus

Indications for Use (Describe)

1. DENTAL SOFT TISSUE INDICATIONS

The indications are identical to the previously cleared predicate systems.

Incision, excision, vaporization, ablation of oral soft tissues including marginal and inter-dental givgival and epithelial lining of free gingival and the following specific indications:

· Exposure of Unerupted teeth
· Fibroma removal
· Frenectomy
· Gingival Troughing for crown impressions
· Gingivectomy
· Gingivoplasty
· Hemostasis and coagulation
· Gingival incision and excision hemostasis
· Implant recovery
· Incision and drainage of abscess
· Leukoplakia
· Operculectomy
· Oral papillectomies
· Pulpotomy as an adjunct to root canal therapy
· Reduction of gingival hypertrophy
· Soft tissue crown lengthening
· Gingival bleeding index
· Excisional and incisional biopsies
· Treatment of aphthous ulcer canker sores and herpetic.
· Vestibuloplasty
1. LASER PERIODONTAL INDICATIONS:

· Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility )

· Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

1. TOOTH WHITENING INDICATIONS
· Laser Assisted whitening/bleaching of teeth.
· Light activation for bleaching materials for teeth whitening.

4. PAIN INDICATIONS:

· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (8/14)

Page 1 of 2

PSC Publishing Services: (703) 403-6740 EF

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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.

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."

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Exhibit # 6

510 (K) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA l990 and 21 CFR §807.92.

The assigned 5l0(k), number is: K162114.

1. Submitter's Identification: ZOLAR TECHNOLGY & MFG CO. INC. 6315 SHAWSON DRIVE, UNIT # 7-8, MISSISSAUGA, ON, L5T L5T 1J2, CANADA
  Contact: Paul Atkins Executive Officer Tel: 905-593-3605 Fax: 1-888-426-7728 e-mail: patkins@zolartek.com

Alternate Contact Dr. Kapil Surana President Tel: 905-593-3605 Fax: 1-888-426-7728 e-mail: kapilsurana@hotmail.com

Date Summary Prepared: November 17, 2016

1. Name of the Device: Photon/Photon Plus
1. Common or Usual Name: Dental Diode Laser
1. Predicate Device Information: Biolase Epic 10 510(k) 121286 Cao Precise SHP 510(k) 123443 Photon/Photon Plus 510(k) 122020

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ட். Device Description:

The Zolar Technology & MFG Co. Inc. Soft Tissue Dental Laser PHOTON/PHOTON PLUS uses a solid state diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to the hand piece that emits the energy to the target site. A visible light (aiming beam) is emitted at the same time to visually assist in identifying the specific treatment location. The Photon/Photon Plus Laser Systems are comprised of a base consol, a detechable delivery system, tips and a wireless footswitch. The Photon/Photon Plus laser is intended to be used by dentist for a variety of oral soft tissue procedures

The original Operator Manual has been revised to reference the additional Pain Indication for use.

6. Indications for Use:

The Photon Series of Dental Diode Lasers are intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The specific indications are as follows:

1. DENTAL SOFT TISSUE INDICATIONS

The indications are identical to the previously cleared predicate systems.

Incision, excision, vaporization, ablation and coagulation of oral soft tissues including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications:

Exposure of Unerupted teeth
Fibroma removal ●
Frenectomy
Gingival Troughing for crown impressions
Gingivectomy
Gingivoplasty
Hemostasis and coagulation
Gingival incision and excision hemostasis
Implant recovery
Incision and drainage of abscess
Leukoplakia
Operculectomy
Oral papillectomies
. Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy
Soft tissue crown lengthening
Gingival bleeding index
Excisional and incisional biopsies
Treatment of aphthous ulcer canker sores and herpetic.
. Vestibuloplasty

2. LASER PERIODONTAL INDICATIONS:

Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including: probe depth, attachment loss and tooth mobility)
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium.

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3. TOOTH WHITENING INDICATIONS

· Laser Assisted whitening/bleaching of teeth.
Light activation for bleaching materials for teeth whitening.

4. PAIN INDICATIONS:

Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The subject devices have been tested for thermal, electrical and mechanical safety, as demonstrated in the previously approved clearance 510(k) 122020 and conform to applicable medical device safety standards, IEC 60825-1 and IEC 60601-2-22.

8. Performance Assessment:

The clinical test for the therapeutic heating device indications listed in item 6 of the IFU have been conducted with human subjects and the performance data table demonstrates that the device can increase the skin temperature to 40 – 45 "c and maintain the effect for at least 10 minutes safely and effectively.

9. Substantial Equivalence:

The purpose of this submission is to consolidate the current Photon Plus Laser Systems (K122020) with a new Pain Indication.

The Subject Device Photon Dental Diode Laser is of a comparable type and substantially equivalent to the currently marketed and approved Photon Plus 510(k) 122020, Biolase Epic 510(k) 121286 and Cao Precise SHP 510(k) 123443 in regard to the primary features of soft tissue surgical and minor pain indications for use. The subject device retains similar overall size and weight together with the similar construction materials and performance in addition to equivalent key features. The subject device has the same intended uses as the predicate devices.

The device modifications to include Pain Indications (IFU) do not potentially alter the fundamental scientific technology of the device. Substantial Equivalence for the Photon/Photon Plus Laser Systems has also been determined through comparison to the cleared predicate devices i.e. Biolase Epic 510(k) 121286 and Cao Precise SHP 510(k) 123443. This submission demonstrates that the Photon Plus Laser systems are safe, as effective and performs as well as the predicate devices indicated above.

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10. Conclusion:

The Device modifications do not potentially alter the fundamental scientific technology of the device. Substantial Equivalence for the Photon/Photon Plus Laser Systems has also been determined through the technical comparison to the cleared predicate devices. This submission demonstrates that the Photon Plus Laser systems are as safe, as effective and performs as well as the predicate devices.

We suggest that there are no significant differences between the subject device, (Photon/Photon Plus) and the predicate devices (Biolase Epic 10/Cao Precise SHP) in terms of indications for use, safety and effectiveness based on electrical, mechanical and environmental test results. With this information and in our opinion the subject device is considered to be substantially equivalent to the predicate devices.

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Subject Device Technological Comparison

| DEVICE NAME | Photon/Photon
Plus | Photon/Photon
Plus | Precise SHP | Epic 10 |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | Zolar Technology Inc | Zolar Technology Inc | Cao Group Inc | Biolase Inc |
| 510(K) | 162114 | 122020 | 123443 | 121286 |
| DIMENSION | 187 -138 -148mm | 187 -138 -148mm | 139 - 120 - 61mm | 145 - 112 - 165mm |
| WEIGHT |