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

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.

TOOTH WHITENING INDICATIONS

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

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.

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

AI/ML Overview

This document describes the Zolar Technology & MFG Co. Inc. Photon and Photon Plus dental diode lasers (K162114). The context for the device's acceptance is a 510(k) premarket notification, which establishes substantial equivalence to previously cleared predicate devices, rather than a novel device requiring extensive clinical trials to prove efficacy. The "study" referenced in the prompt is a performance assessment focusing on a specific new indication (pain relief) by demonstrating thermal effects.

Here's the breakdown based on the provided text:

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

For the specific "Pain Indications," the acceptance criteria involve demonstrating an increase in skin temperature to 40-45°C, maintained for at least 10 minutes, safely and effectively. The reported device performance meets these criteria.

Acceptance Criteria (Pain Indications)	Reported Device Performance
Increase skin temperature to 40-45°C	Demonstrated that the device can increase the skin temperature to 40-45°C
Maintain the effect for at least 10 minutes	Maintained the effect for at least 10 minutes
Safely and effectively	Performed safely and effectively

For the other indications (Dental Soft Tissue, Laser Periodontal, Tooth Whitening), the acceptance criteria are based on substantial equivalence to predicate devices, meaning the device performs "as safe, as effective, and performs as well as" the predicate devices. The performance is reported as being similar or identical to the 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)

Sample size: For the "Pain Indications," the clinical test was conducted with "human subjects," but the exact number of subjects is not specified in the provided document.
Data provenance: The document does not explicitly state the country of origin of the data. It mentions Zolar Technology & Mfg Co. Inc. is based in Mississauga, CA (Canada), but this doesn't confirm the location of the clinical test. The test was prospective as it involved a "clinical test... conducted with human subjects."

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)

This information is not provided in the document. The study described focuses on quantitative thermal measurements rather than expert interpretation of complex medical images or diagnoses.

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

This information is not provided. Given the nature of the "performance assessment" for pain relief (temperature measurement), formal adjudication as seen in imaging studies (e.g., for diagnostic accuracy) is not typically applicable in the same way.

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 not an AI-assisted device, nor is it a diagnostic imaging device that would typically undergo an MRMC study. The device is a therapeutic laser.

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

Not applicable. This device is a laser intended for direct use by a dentist; it does not operate as an algorithm or with human-in-the-loop AI assistance. The performance assessment pertains to the device's physical effect on tissue.

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

For the "Pain Indications" where a performance assessment was conducted, the ground truth was physiological measurement (skin temperature) and observed effect (maintenance over time, safety, and effectiveness).

For other indications (Dental Soft Tissue, Laser Periodontal, Tooth Whitening), the "ground truth" for substantial equivalence is based on the established performance and safety of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This device is a hardware laser, not a machine learning algorithm that requires a training set. The performance assessment is a validation of the device's physical capabilities.

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

Not applicable (as explained in point 8).

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

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

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

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

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."

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

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

{5}------------------------------------------------

ட். Device Description:

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.

{6}------------------------------------------------

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.

{7}------------------------------------------------

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.

{8}------------------------------------------------

Subject Device Technological Comparison

DEVICE NAME	Photon/PhotonPlus	Photon/PhotonPlus	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	<2.0 kg	<2.0 kg	<2.0 kg	1.1 kg
LASER TYPE	Diode	Diode	Diode	Diode
LASERCLASSIFICATION	4	4	4	4
MAXIMUMPOWER	3 watts Photon10 watts Photon Plus	3 watts Photon10 watts Photon Plus	3 watts	10 watts
OPERATIONMODE	Continuous / Pulse	Continuous / Pulse	Continuous / Pulse	Continuous / Pulse
WAVELENGTH	810 nm Photon980 nm Photon Plus	810 nm Photon980 nm Photon Plus	810 nm	940 nm
AUDIBLENOTIFICATION	Yes	Yes	Yes	Yes
VISUALNOTIFICATION	Yes	Yes	Yes	Yes
POWERREQUIREMENTS	AC100 ~ 240V50/60Hz	AC100 ~ 240V50/60Hz	AC100 ~ 240V50/60Hz	AC100 ~ 240V50/60Hz
WIRELESS FOOTPEDAL	Frequency: 2.4 GHz	Frequency: 2.4 GHz	Frequency: 2.4 GHz	Frequency: 2.4 GHz
INDICATIONSFOR USE	Same as thoseIndications cleared asper K122020,K123443, K121286	Approved Indicationsas per K122020	Approved Indicationsas per K123443	ApprovedIndications as perK121286
Predicate	Photon/Photon Plus	Photon/Photon Plus	Precise SHP	Epic 10
510(k) No.	K162114	K122020	K123443	K121286
Indications ForUse	Dental Soft TissueIndicationsIncision, excision,vaporization, ablation andcoagulation of oral softtissues including marginaland inter-dental gingival andepithelial lining of freegingival and the followingspecific indications:• Exposure of Uneruptedteeth• Fibroma removal• Frenectomy• Gingival Troughing forcrown impressions• Gingivectomy• Gingivoplasty• Hemostasis andcoagulation• Gingival incision andexcision hemostasis• Implant recovery• Incision and drainage ofabscess• Leukoplakia• Operculectomy• Oral papillectomies• Pulpotomy as an adjunctto root canal therapy• Reduction of gingivalhypertrophy• Soft tissue crownlengthening• Gingival bleeding index• Excisional and incisionalbiopsies• Treatment of aphthousulcer canker sores andherpetic.• Vestibuloplasty.Laser PeriodontalIndications• Sulcular debridement(removal of diseased orinflamed soft tissue in theperiodontal pocket toimprove clinical indicesincluding: probe depth,attachment loss andtooth mobility)• Removal of highlyinflamed edematoustissue affected bybacteria penetration ofthe pocket lining andjunctional epithelium.	Dental Soft TissueIndicationsIncision, excision,vaporization, ablation andcoagulation of oral softtissues including marginaland inter-dental gingivaland epithelial lining of freegingival and the followingspecific indications:• Exposure of Uneruptedteeth• Fibroma removal• Frenectomy• Gingival Troughing forcrown impressions• Gingivectomy• Gingivoplasty• Hemostasis andcoagulation• Gingival incision andexcision hemostasis• Implant recovery• Incision and drainage ofabscess• Leukoplakia• Operculectomy• Oral papillectomies• Pulpotomy as an adjunctto root canal therapy• Reduction of gingivalhypertrophy• Soft tissue crownlengthening• Gingival bleeding index• Excisional and incisionalbiopsies• Treatment of aphthousulcer canker sores andherpetic.• VestibuloplastyLaser PeriodontalIndications• Sulcular debridement(removal of diseased orinflamed soft tissue inthe periodontal pocketto improve clinicalindices including: probedepth, attachment lossand tooth mobility)• Removal of highlyinflamed edematoustissue affected bybacteria penetration ofthe pocket lining andjunctional epithelium.• Laser Soft Tissue Curettage	Dental Soft Tissue IndicationsDentistry and oral soft tissuesincluding:• Incision, excision• Vaporisation• Ablation• Exposure of Uneruptedteeth• Fibroma• Frenectomy• Gingival Troughing• Gingivectomy• Gingivoplasty• Hemostasis• Gingival incision andexcision hemostasis• Implant exposure• Incision and drainage ofabscess• Leukoplakia• Operculectomy• Oral papillectomies• Pulpotomy• Reduction of gingivalhypertrophy• Crown lengthening• Gingival bleeding index• Excisional and incisionalbiopsies• Treatment of aphthousulcer canker sores andherpetic.• VestibuloplastyLaser Periodontal Indications• Sulcular debridement(removal of diseased orinflamed soft tissue in theperiodontal pocket toimprove clinical indicesincluding: probe depth,attachment loss and toothmobility)• Removal of highly inflamededematous tissue affectedby bacteria penetration ofthe pocket lining andjunctional epithelium.	Dental Soft Tissue IndicationsIncision, excision, vaporization,ablation and coagulation oforal soft tissues includingmarginal and inter-dentalgingival and epithelial lining offree gingival and the followingspecific indications:• Exposure of Uneruptedteeth• Fibroma removal• Frenectomy• Gingival Troughing forcrown impressions• Gingivectomy• Gingivoplasty• Hemostasis andcoagulation• Gingival incision andexcision hemostasis• Implant recovery• Incision and drainage ofabscess• Leukoplakia• Operculectomy• Oral papillectomies• Pulpotomy as an adjunct toroot canal therapy• Reduction of gingivalhypertrophy• Soft tissue crownlengthening• Tissue Retraction forimpression• Excisional and incisionalbiopsies• Treatment of aphthousulcer canker sores andherpetic.• VestibuloplastyLaser Periodontal Indications• Sulcular debridement(removal of diseased orinflamed soft tissue in theperiodontal pocket toimprove clinical indicesincluding: probe depth,attachment loss and toothmobility)• Laser removal of diseased.Infected, inflamed andnecrosed soft tissue withinthe periodontal pocket.• Laser Soft TissueCurettage.
Predicate	Photon/Photon Plus	Photon/Photon Plus	Precise SHP	Epic 10
510(k) No.	K162114	K122020	K123443	K121286
Indications ForUse	Tooth WhiteningIndications• Laser Assistedwhitening/bleaching ofteeth.• Light activation forbleaching materials forteeth whitening.Pain Indications• Topical heating for thepurpose of elevating tissuetemperature for atemporary relief of minormuscle and joint pain andstiffness minor arthritispain, or muscle spasm,minor sprains and minormuscular back pain; thetemporary increase in localblood circulation; thetemporary relaxation ofmuscle.	Tooth WhiteningIndications• Laser Assistedwhitening/bleaching ofteeth.• Light activation forbleaching materials forteeth whitening.	Tooth WhiteningIndications• Laser Assistedwhitening/bleaching ofteeth.• Light activation forbleaching materials forteeth whitening.Pain Indications• Topical heating for thepurpose of elevatingtissue temperature for atemporary relief ofminor muscle and jointpain and stiffness minorarthritis pain, or musclespasm, minor sprainsand minor muscularback pain; thetemporary increase inlocal blood circulation;the temporaryrelaxation of muscle.	Tooth WhiteningIndications• Laser Assistedwhitening/bleaching ofteeth.• Light activation forbleaching materials forteeth whitening.Pain Indications• Topical heating for thepurpose of elevatingtissue temperature for atemporary relief of minormuscle and joint pain andstiffness minor arthritispain, or muscle spasm,minor sprains and minormuscular back pain; thetemporary increase inlocal blood circulation;the temporary relaxationof muscle.

{9}------------------------------------------------

Subject Device Indications For Use Comparisons

{10}------------------------------------------------

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.