(330 days)
Not Found
No
The summary describes a diode laser device for oral soft tissue procedures and tooth whitening. There is no mention of AI, ML, image processing, or any data-driven decision-making components in the device description, intended use, or performance studies. The device operates based on laser energy delivery via a fiber and handpiece, activated by a footswitch.
Yes
The device performs various therapeutic procedures on oral soft tissue, such as excision, vaporization, ablation, and coagulation, as well as laser periodontal procedures and tooth whitening.
No
The device is described as a "surgical device" used for "excision, vaporization, ablation and coagulation of oral soft tissue procedures" and "tooth whitening." These are treatment procedures, not diagnostic ones. While "Excisional and incisional biopsies" are listed, these are procedures for taking samples for diagnosis, not the diagnostic act itself performed by the device.
No
The device description explicitly states it is a "surgical device" utilizing a "solid state diode a laser energy source" delivered via a "flexible fiber connecting the laser source and the handpiece," activated by a "footswitch." These are all hardware components, indicating it is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Photon/Photon Plus Diode Laser is a surgical device used for excision, vaporization, ablation, and coagulation of oral soft tissue. It directly interacts with the patient's tissue during procedures.
- Intended Use: The intended use clearly describes surgical procedures performed directly on the patient's oral tissue, not tests performed on samples outside the body.
- Device Description: The description details a laser system that delivers energy to the operating area via a fiber and handpiece, consistent with a surgical tool.
Therefore, the Photon/Photon Plus Diode Laser is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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, 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 ...
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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Photon/Photon Plus is intended for use by dentists in oral soft tissue and tooth whitening procedures.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissue, periodontal pocket, teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentists
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, 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.
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
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.
1
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.
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.
2
- . 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:
3
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 | |
| or | |
| inflamed soft tissue in the periodontal | dental soft tissue indications including: incision, |
| pocket to to improve clinical | |
| indices | 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 |
:
4
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 of |
| diseased, infected, inflamed and necrosed soft | |
| inflamed soft tissue in the periodontal | |
| pocket 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). | |
.
:
5
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 for
incision/excision, vaporazation;
abalation and coagulation of
soft tissues;
Dental laser operation incl. light
activation of bleathing materils
for 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 7
watts | 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 Membrane
Touch 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/Visual
Notification | Yes | Yes |
| Autoclave | Hand Piece Autoclavable | Hand Piece Autoclavable |
| Applicable standards | IEC 60825-1
IEC 60601-2-22 | IEC 60825-1
IEC 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 ·
10
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)
OR
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