The Photon is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . 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 PROCEDURES: - 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 Indications for Use for Photon Plus: The Photon Plus is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows: SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation. - . Exposure of Unerupted teeth - Excision of lesion or removal of Granulation tissue . - . 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 PROCEDURES: - 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) - Debridement of diseased epithelial lining . TOOTH WHITENING INDICATIONS - Laser assisted whitening/bleaching of teeth . - Light activation for bleaching materials for teeth whitening. .

Device Description

Photon/Photon Plus Diode Laser is a surgical device at the cutting edge of technology, designed for a wide variety of oral soft tissue and tooth whitening procedures with the wavelength of 980nm and the power range of 100mW to 10W. Photon Series Diode Laser utilizes a solid state diode a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.

AI/ML Overview

The provided text describes a 510(k) summary for the Zolar Photon/Photon Plus dental diode lasers. This submission focuses on establishing substantial equivalence to predicate devices rather than proving specific performance criteria through a dedicated study with acceptance criteria.

Therefore, the requested information regarding acceptance criteria and a study proving their fulfillment is not explicitly present in the provided document, as the submission relies on demonstrating equivalence to already cleared devices. No clinical studies were performed.

However, based on the non-clinical tests performed, we can infer some aspects and highlight what is mentioned:

Inferred Acceptance Criteria and Reported Device Performance

Since no clinical studies were performed for this 510(k) submission, there are no specific performance criteria results from a clinical trial. The "acceptance criteria" here are inherent to demonstrating substantial equivalence and conformity to relevant safety standards.

Acceptance Criteria (Inferred from Substantial Equivalence and Standards)	Reported Device Performance (from Non-Clinical Tests)
Safety (Thermal, Electrical, Mechanical)	Conformity to IEC 60825-1, IEC 60601-2-22
Design Specifications	Met all design specifications
Compliance to Standards	Compliance to ANSI/AAMI ST79, AAMI TIR 12, ANSI/AAMI/ISO 17665-1, ANSI/AAMI ST77, ANSI/AAMI ST81, ISO 17664, ANSI/AAMI ST67, ANSI/AAMI ST8, EN 556
Performance Equivalence	- Wavelength: 980nm (Photon Plus), 810nm/980nm (Photon) (Comparable to predicates)- Wattage: 0.1-10W (Photon Plus), 0.1-3.0W/0.1-10W (Photon) (Comparable to predicates)- Operating Modes: Pulsed or CW (Comparable to predicates)
Intended Use Equivalence	Intended uses are substantially equivalent to predicate devices.

Study Details (as per Request, but largely "Not Applicable" or "Not Provided" in this context)

Sample Size used for the test set and the data provenance:
- Sample Size: Not applicable. No clinical test set. Non-clinical tests were performed on the device itself.
- Data Provenance: Not applicable. The "study" here is a submission demonstrating substantial equivalence through non-clinical testing and comparison to predicate devices, not a clinical trial with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There was no clinical test set requiring expert ground truth establishment.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical test set.
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 device is a laser surgical instrument, not an AI-assisted diagnostic or imaging device. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device (laser), not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for clinical ground truth. For non-clinical tests, engineering specifications and compliance to standards served as the "ground truth" for evaluating the device's performance against established safety and design requirements.
The sample size for the training set:
- Not applicable. This is a physical device, not a machine learning model requiring a training set.
How the ground truth for the training set was established:
- Not applicable.

Summary regarding the "Study":

The document explicitly states: "9. Discussion of Clinical Tests Performed: Not Applicable" and "10. Conclusion: We have demonstrated that there are no significant differences between the subject devices, and the predicate devices, Photon/Photon Plus and the predicate devices, Picasso/Picasso Lite Dental Diode Lasers, K102359, and stLase Dental Laser, K111689, in terms of safety and effectiveness based on electrical, mechanical and environmental test results."

This clearly indicates that no clinical studies with acceptance criteria, patient samples, or expert ground truth were conducted for this 510(k) submission. The regulatory pathway chosen was based on demonstrating substantial equivalence through non-clinical testing and comparison of technical specifications and intended uses with legally marketed predicate devices.

Summary

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510(K) SUMMARY

ﻠﺴﻠﺴﻠﺔ

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

The assigned 510(k) number is K122020.

1. Submitter's Identification:

ZOLAR TECHNOLGY & MFG CO. INC. 6033 SHAWSON DRIVE, UNIT #19, MISSISSAUGA, ON, L5T 1H8, CANADA

Contact:

Joginder (Joe) Pal General Manager

TEL : 905-593-3605/ 905-581-5235 FAX: 1-888-426-7728 EMAIL: SALES@ZOLARTEK.COM

Date Summary Prepared: June 3, 2013

2. Name of the Device:

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

3. Common or Usual Name:

Dental Diode Laser

4. Predicate Device Information:

Picasso/Picasso Lite Dental Diode Lasers, K102359

stLase Dental Laser, K111689

ડ. Device Description:

The Photon/Photon Plus is intended for use by dentists in oral soft tissue and tooth whitening procedures.

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Photon Series Diode Laser utilizes a solid state diode a laser energy source. The energy is delivered to the operating area by means of a delivery system consisting of a flexible fiber connecting the laser source and the handpiece. The device is activated by means of a footswitch.

6. Intended Use:

The Photon is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:

SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.

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 PROCEDURES:

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

Indications for Use for Photon Plus:

The Photon Plus is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:

SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.

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. Exposure of Unerupted teeth
Excision of lesion or removal of Granulation tissue .
. 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 PROCEDURES:

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)
Debridement of diseased epithelial lining .

TOOTH WHITENING INDICATIONS

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

7. Comparison to Predicate Devices:

The subject device is of a comparable type and substantially equivalent to the previously licensed Picasso and Picasso Lite marketed by AMD Lasers LLC and the stLase by Dental Photonics, Inc. To facilitate the comparison, the principal features of the subject devices are listed side-by-side with the predicate devices. Refer to the comparison table shown below:

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Zolar Photon Plus and Stlase IFU Comparison Chart

Zolar Photon Plus (subject)	St Lase Predicate (K111689)
Exposure of Unerupted teeth	incision, excision, vaporization, ablation,
Excision of lesion or removal of Granulation tissue	removal of granulation tissue,
Frenectomy
Gingival Troughing for crown impressions	Frenectomy, Frenotomy,
Gingivectomy	gingival troughing, crown lengthening,
Gingivoplasty	gingivectomy,
Hemostasis and coagulation	gingivoplasty,
Gingival incision and excision hemostasis	hemostasis, or coagulation of intraoral and
	extraoral soft tissue (including marginal and
	interdental gin giva and epithelial lining of free gin
Implant recovery	giva)
Incision and drainage of abscess	implant recovesry/uncovery,
Leukoplakia	incisions and draining of abscesses
Operculectomy	Leukoplakia
Oral papillectomies	operculectomy
Pulpotomy as an adjunct to root canal therapy	papillectomy
Reduction of gingival hypertrophy	pulpotomy as an adjunct to root canal therapy
	papillectomy
Soft tissue crown lengthening
Gingival bleeding index	crown lengthening
Excisional and incisional biopsies	gingival troughing
	biopsy
Treatment of aphthous ulcer, canker sores and
herpetic
Vestibuloplasty.	Treatment of aphthous ulcers
LASER PERIODONTAL PROCEDURES:	vestibuloplasy,
Sulcular debridement (removal of diseased
orinflamed soft tissue in the periodontal	dental soft tissue indications including: incision,
pocket to to improve clinicalindices	exci sion, vaporization, ablation,
including:, probe depth, attachment loss	biopsy,
and tooth mobility)	removal of granulation tissue,
	laser assisted flap surgery, debridement of diseased
Debridement of diseased epithelial lining	epithelial lining, , tissue retraction for impressions,
	, excision of lesions, leukoplakia, removal of
TOOTH WHITENING INDICATIONS	hyperplastic tissues, and removal of hyperplastic
	tissues, , sulcular debridement (removal of diseased
Laser assisted whitening/bleaching of teeth	or inflamed soft tissue in the periodontal pocket),.
Light activation for bleaching materials for teeth	and light activation of bleaching materials for teeth
whitening.	whitening

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Zolar Photon and Picasso IFU Comparison Chart

Zolar Photon(subject)	Picasso Predicate(K102359)
Exposure of Unerupted teeth	Exposure of unerupted teeth
Fibroma removal	Fibroma removal
Frenectomy	Frenectomy and frenotomy
Gingival Troughing for crown impressions	Gingival troughing for crown impression
Gingivectomy	Gingivectomy
Gingivoplasty	Gingivoplasty
Hemostasis and coagulation	Hemostasis and coagulation
Gingival incision and excision hemostasis	Gingival incision and excision
Implant recovery	Implant recovery
Incision and drainage of abscess	Incision and drainage of abscess
Leukoplakia	Leukoplakia
Operculectomy	Operculectomy
Oral papillectomies	Oral papillectomnies
Pulpotomy as an adjunct to root canal therapy	Pulpotomy as an adjunct to root canal therapy
Reduction of gingival hypertrophy	Reduction of gingival hypertrophy
Soft tissue crown lengthening	Soft tissue crown lengthening
Gingival bleeding index	Gingival bleeding index,probe depth, attachment loss,and tooth mobility
Excisional and incisional biopsies

Treatment of aphthous ulcer, canker sores and	Treatment of canker sores, herpetic and aphthous
herpetic	ulcers of the oral mucosa
Vestibuloplasty.	Vestibuloplasty
	Excisional and incisional biopsies
LASER PERIODONTAL PROCEDURES:

Sulcular debridement (removal of diseased or	Sulcular debridement (curettage, removal ofdiseased, infected, inflamed and necrosed soft
inflamed soft tissue in the periodontalpocket to improve clinical indices	tissue in the periodontal pocket to improve clinical
including:, probe depth, attachment loss	indices including: gingival index, gingival bleeding
and tooth mobility)	index, probe depth, attachment loss and tooth
	mobility).
Removal of highly inflamed edematous tissue	Removal of highly inflamed edematous tissue
affected by bacteria penetration of the	affected by bacteria penetration of
pocket lining and junctional epithelium	the pocket lining and junctional epithelium.
	Picasso assisted new attachment procedure
	(cementum-mediated periodontal ligament
	new-attachment to the root surface in the absence
	of long junctional epithelium).

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Comparison of Stlase and Zolar Photon Plus (Technical Specifications)

Specifications	Dental Photonics StLase(K11689)	Zolar--Photon Plus(Subject Device)
Wavelength
	980 nm	980nm
Power
	25 w	10 W
Power range	0.5-25w	100mW to 10W
Increments
	0.1-0.5w	0.1 w
Operating modes
	Pulsed or CW	Pulsed or CW
Amining beam	650 nm, 5mW	650nm, 2 mW
Cooling
	Air cooled, closed control water	Air cooled
Weight
	around 1.8 KG	around 1.2 KG
Power requirements		120v/60 HZ or 240 V to charge-
	120v/60 HZ or 240 V/50HZ	Battery
Sterilization method	Steam autoclave	Steam autoclave
Physical Media Source	Diode	Diode
Wattage	0.5 to 25 watts	0.1 to 10 watts
Control Panel	Color Touch screen	Colour Touch screen
Settings		22 Treatable & 3 customizable
Frequency	20,000Hz	1-5000Hz
Pulse Interval	0.025ms - 3ms	0.1ms-9.9s
Pulse Energy	Continuouse & Pulse Modes	Continuouse & Pulse Modes
Laser Clasification	Class 4	Class 4
Aiming Beam	650nm, 5mW	3 levels of Intensity
Foot Switch Operation		Yes
Dental Applications	Deatal Soft Tissue indications;General surgey forincision/excision, vaporazation;abalation and coagulation ofsoft tissues;Dental laser operation incl. lightactivation of bleathing materilsfor tooth whitenting.	Soft Tissue Surgery Periodontal& Hygiene Endodontic,Whitening / Bleaching.
Autoclave	Hand Piece Autoclavable	Hand Piece Autoclavable

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

Specifications	Picasso Lite/Picasso(K102359)	Zolar-Photon/Photon Plus(Subject Device)
Physical Media Source	Diode	Diode
Wattage	0.1 to 2.5 watts / 0.1 to 7watts	0.1 to 3.0W / 0.1 to 10 watts
Wavelength nm	810 nm	810 nm/980 nm
Control Panel	Color Touch Screen /Universal Icon MembraneTouch screen	Color Touch screen
Settings	8 Treatable (prest values) /Manual	22/23 Treatable & customizable
Pulse Energy	Continuous & Pulse Modes	Continuous & Pulse Modes
Delivery Fiber Diameter	200-1000um	200-1000um
Laser Classification	Class 4	Class 4
Aiming Beam	Variables (adjustable)	Variables ( 3 settings)
Foot Switch Operation	Yes	Yes
Audible/VisualNotification	Yes	Yes
Autoclave	Hand Piece Autoclavable	Hand Piece Autoclavable
Applicable standards	IEC 60825-1IEC 60601-2-22	IEC 60825-1IEC 60601-2-22

Comparison of Picasso/Picasso Lite and Zolar Photon (Technical Specifications)

The Photon Plus / Photon Dental Diode Lasers are of a comparable type and substantially equivalent to the currently marketed Picasso / Picasso Lite (K102359) and stLase Dental Lasers (K111689). Although the subject devices are somewhat smaller and lighter than Picasso devices, the overall construction, materials and performance as well as key features are equivalent. The subject devices have the same intended uses as the predicate devices and the Photon Plus subject device includes features which are well established on the stLase Dental Laser systems.

Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence 8. are as follows:

The subject devices have been tested for thermal, electrical and mechanical safety, and conform to applicable medical device safety standards, IEC 60825-1 and IEC 60601-2-22.

Testing was conducted to validate and verify that the Photon/Photon Plus devices met all design specifications and were substantially equivalent to the predicate devices.

Photon/Photon Plus have also been tested to assure compliance to the requirements of various published standards, including ANSI/AAMI ST79, AAMI TIR 12, ANSI/AAMI/ISO 17665-1, ANSI/AAMI ST77, ANSI/AAMI ST81, ISO 17664, ANSI/AAMI ST67, ANSI/AAMI ST8, EN 556.

9. Discussion of Clinical Tests Performed:

Not Applicable

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

10. Conclusion:

We have demonstrated that there are no significant differences between the subject devices, and the predicate devices, Photon/Photon Plus and the predicate devices, Picasso/Picasso Lite Dental Diode Lasers, K102359, and stLase Dental Laser, K111689, in terms of safety and effectiveness based on electrical, mechanical and environmental test results. Based on this information, the 8subject devices are substantially equivalent to the predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/8/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Letter dated: June 5, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Zolar Technology & Mfg. Co., Inc. % MDI Consultants, Inc. Ms. Susan D. Goldstein-Falk 55 Northern Boulevard, Suite 200 Great Neck, New York 11021

Re: K122020 -

Trade/Device Name: Photon/Photon Plus Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general surgery and Plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: May 17, 2013 Received: May 20, 2013

Dear Ms. Goldstein-Falk:

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

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

Page 2 - Ms. Susan D. Goldstein-Falk

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark Nielkerson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health-

Enclosure ·

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Page 1 of 3

Indications for Use

510(k) Number (if known): K122020

Device Name: Photon/Photon Plus

Indications for Use for Photon:

The Photon is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:

SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.

. 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 PROCEDURES:

· 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

Neil R Ogden Nell R Ogden
2013.06.04 09:27:24:04 09:27:24 04:00

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number K122020

{11}------------------------------------------------

Indications for Use for Photon Plus:

The Photon Plus is intended for use by dentists for excision, incision, vaporization, ablation and coagulation of oral soft tissue procedures. The specific applications are as follows:

SOFT TISSUE: The metal handpiece with cutting fiber does not have any direct contact to the soft tissue, skin or cell during the operation.

Exposure of Unerupted teeth .
Excision of lesion or removal of Granulation tissue .
t Frenectomy
◆ Gingival Troughing for crown impressions
. Gingivectomy
Gingivoplasty �
0 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 ...

Neil R Ogdens 2013.06.04 09:27-52 -04'00"

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

{12}------------------------------------------------

LASER PERIODONTAL PROCEDURES:

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)
Debridement of diseased epithelial lining

TOOTH WHITENING INDICATIONS

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

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Neil R Ogdena Ma

2013.06.04 09:28:26-04'00'_

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number __K122020

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.