(26 days)
Not Found
No
The device description focuses on the laser technology and its operational modes (continuous wave or pulse) controlled by the operator via a footswitch and membrane switch pad. There is no mention of AI, ML, or any form of automated decision-making or data analysis that would typically indicate the presence of such technology. The performance studies described are focused on power density and safety, not algorithmic performance.
Yes.
The device's intended uses explicitly involve the "treatment of oral soft tissue" and numerous specific therapeutic procedures like "fibroma removal," "pulpotomy," "reduction of bacterial level (decontamination) and inflammation," and "treatment of aphthous ulcers."
No
The device is described as a laser for surgical procedures (incision, excision, ablation, vaporization, hemostasis, and treatment) of oral soft tissue, not for diagnosis.
No
The device description clearly details hardware components such as a laser source (Gallium Aluminum Arsenide diode lasers), a fiber optic cable delivery system, a footswitch, and an electro-mechanical interface (membrane switch pad). These are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes procedures performed directly on the patient's oral soft tissue (incision, excision, ablation, etc.). IVDs are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information about a patient's health.
- Device Description: The device description details a laser system designed to deliver energy to tissue. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic testing.
The device is a therapeutic laser intended for direct treatment of oral soft tissues.
N/A
Intended Use / Indications for Use
The QuickLase™DUALand QuickLase™810/980 Dental Lasers are intended for incision, excision, ablation, vaporization, and/or coagulation of oral soft tissues (including marginal and interdental gingival and epithelial lining of free gingiva). It is also intended for light activation for bleaching materials for teeth whitening, and laser assisted bleaching/whitening for teeth whitening.
For the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.
Examples:
Excisional and incisional biopsies
Exposure of unerupted teeth
Fibroma removal
Gingivoplasty
Hemostasis and coagulation
Incision and drainage of abscess
Operculectomy
Oral papillectomies
Pulpotomy
Reduction of gingival hypertrophy
Soft Tissue crown lengthening
Vestibuloplasty
Laser Soft Tissue Curettage
Treatment of canker sores, herpetic and other ulcers of the oral mucosa
Tissue Retraction
Frenectomy and Frenotomy
Gingival Troughing for crown impressions
Gingivectomy
Ginigival incision and excision
Implant Recovery
Leukoplakia
Pulpotomy as an adjunct to root canal therapy
Reduction of bacterial level (decontamination) and inflammation
Treatment of aphthous ulcers
Lesion (tumor) removal
Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket
Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithlium
Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility
Light activation of bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The laser source of the QuickLase™DUALDental Lasers or QuickLase™810/980 Dental Laser is an array of Gallium Aluminum Arsenide (GaAlAs), solid state, semiconductor diode lasers. The individual lasers comprising the array are capable of producing invisible infrared laser energy at either 810 or 980 nanometers depending upon the concentration of and construction of the epitaxial layers of the diode. The delivery system consists of a fiber optic cable with a nominal diameter of 400 microns. In all available configurations, that portion of the delivery system that is handled by the operator and/or in contact with the patient can be sterilized by heat, steam, gas, chemicals or combinations thereof. Activation of the laser occurs after the operator either selects or enters the parameters for the procedure, verifies and authorizes the parameters and depresses a footswitch which fires the laser. The footswitch is an on/off switch. The interface for input is electro-mechanical by way of a membrane switch pad. The laser operates in continuous wave or pulse mode which is selected and/or verified by the operator. A visible aiming beam is provided in the form of a visible red laser which emits not more than 5mW (user adjustable and verified) in the 640-650 nanometer wavelength range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance: None
Non-Clinical Performance: Tests confirm that the power densities for treatment are identical in all devices insuring that all devices provide the exact same efficacy. Similar power density and safety controls insure equivalent or superior safety performance to the comparison device.
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.
K072295, K063384, K062258, K053161, K030539
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
QuickLase Limited Traditional 510(K)-QuickLase™DUAL+ QuickLase™ 810/980
510(K) Summary
し QuickLase Limited
MAR 1 6 2010
| Submitter: | QuickLase Limited
Rosalind Nahab
Director
18 Dover Street
Canterbury, Kent CT1 3HD
United Kingdom | MAR 1 6 2010 |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Preparer & Contact: | Calvin D. Ostler
Agent and E-contact
PO Box 1264
1094 West Greasewood Drive
Riverton, Utah 84065
Phone: 801-831-5331
Email: CalOstler@msn.com | |
| Preparation Date: | February 9, 2010 | |
| Device Trade Name: | QuickLase™DUAL+ Dental Laser
QuickLase™ (810nm) Dental Lasers
QuickLase™ (980nm) Dental Lasers | |
| Common Name: | Dental Diode Laser | |
| Classification Name: | Instrument, surgical, powered, laser | |
| Regulation Description: | 878.4810 Laser surgical instrument for use in general and
plastic surgery and 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 | |
| Product Code: | GEX | |
This document including any attachments may confidential information, privileged material or otherwise constitute non-public information by contract of all alle contain proprietary, contestial merinent pronogother than the intended pay is prohibited. I four niomation by contact of law. Any been mornition the Reserved the Research on one of the more of the more of the semination, verieted ins occanent in effor, please inniedately lectific and action of your of real of your your your versions is not authorized and may be inlay be in
1
| Device Class | 2 |
|---|---|
| Review Panel | General & Plastic Surgery |
| Equivalent Device: | TwinWave and TidalWave by Lumen Development and |
| Manufacturing, Inc., a California Corporation, K072295 | |
| AND | |
| DioDent Micro 980/810 by Hoya Conio, Inc, K063384 | |
| Odyssey Navigator Diode Laser by Ivoclar Vivadent Inc, | |
| K062258 | |
| SIROLaser by Sriona Dental Systems, GmbH, K053161 | |
| LaserSmile by BioLase Technology, Inc., K030539 | |
| Device Description: | The laser source of the QuickLase™DUALDental Lasers or |
| QuickLase™810/980 Dental Laser is an array of Gallium | |
| Aluminum Arsenide (GaAlAs), solid state, semiconductor | |
| diode lasers. The individual lasers comprising the array are | |
| capable of producing invisible infrared laser energy at either | |
| 810 or 980 nanometers depending upon the concentration of | |
| and construction of the epitaxial layers of the diode. The | |
| delivery system consists of a fiber optic cable with a nominal | |
| diameter of 400 microns. In all available configurations, that | |
| portion of the delivery system that is handled by the operator | |
| and/or in contact with the patient can be sterilized by heat, | |
| steam, gas, chemicals or combinations thereof. Activation of | |
| the laser occurs after the operator either selects or enters | |
| the parameters for the procedure, verifies and authorizes the | |
| parameters and depresses a footswitch which fires the laser. | |
| The footswitch is an on/off switch. The interface for input is | |
| electro-mechanical by way of a membrane switch pad. The | |
| laser operates in continuous wave or pulse mode which is | |
| selected and/or verified by the operator. A visible aiming | |
| beam is provided in the form of a visible red laser which | |
| emits not more than 5mW (user adjustable and verified) in | |
| the 640-650 nanometer wavelength range. | |
| Intended Use: | The QuickLase™DUALand QuickLase™810/980 Dental |
| Lasers are intended for incision, excision, ablation, | |
| vaporization, and/or coagulation of oral soft tissues | |
| (including marginal and interdental gingival and epithelial | |
| lining of free gingiva). It is also intended for light activation |
nomarios by onlast of als costined the mornition that in the more one that in home of the provincial of por system.
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2
for bleaching materials for teeth whitening, and laser assisted bleaching/whitening for teeth whitening.
Comparison:
The QuickLaseDUAL, QuickLase810, and QuickLase980, Diode Dental Laser Systems in their various configurations are, in fact, the TwinWave, TidalWave810, and TidalWave980 Diode Dental Lasers Systems that were cleared by the FDA on December 18, 2007 under 510(K) Number: K072995. The applications having been submitted by Lumen Development and Manufacturing, Inc. a California Corporation. We, QuickLase Limited, entered into a joint development agreement for these devices and, by the terms of the contract, were given rights in Europe. We obtained CE testing and marking and launched these lasers under the tradename QuickLaseDUAL+, QuickLase810, and QuickLase980. These lasers have performed flawlessly in Europe in thousands of procedures over the past 2 years. Lumen Development and Manufacturing, Inc., a California Corporation, fell under hard times and is out of business. According to the terms in our contract we are now able to market the devices in the USA. We are, therefore, applying for 510(K) clearance from the FDA for marketing the devices in the USA. With a notable caveat; these lasers are not substantially equivalent to, they are identical in terms of safety and efficacy. The only difference between the approved devices under 510(K) number K072995 and the devices covered in this application are the brandname change from TwinWave, TidalWave 810, and TidalWave980 to, QuickLaseDUAL+, QuickLase810, and QuickLase980 respectively, and some cosmetic differences in the housings. The units operate exactly the same and produce exactly the same results.
None the less, we offer the exact same narrative in this Summary as was submitted in and cleared in 510(k) Number K072995:
This document including any attachments may confidential information, privileged material or other wise and in and in and in and in and in and in and in and in and in and nt in the booking any elterments hay online propriodary, somiterials by anyone other than the interest prohibited. If your in the interest probles of your homilation by contact of raw. Ally disernent and in the remation the risens of the recomment. Use, dissemination, and may and may and may and may any ve received in enot, press infinedicty fective information contained herein by united by sons is not authorized and may be unlawful.
3
QuickLase Limited
Traditional 510(K)-QuickLase™DUAL+ QuickLase™ 810/980
The QuickLase™DUALDental Laser produces a power range of . 1-5 Watts of 980nanometer laser energy and .1-5watts of 810nanometer laser energy; a combination of .1-10watt of invisible infrared energy. The QuickLase™810/980 980 Dental Laser produces a power range of .1-10 Watts of 980nanometer invisible infrared energy. The QuickLase™810/980 810 Dental Laser produces a power range of .1-10 Watts of 810nanometer invisible infrared energy. An operator adjustable visible red aiming beam is incorporated by way of solid state 640-650nanometer range solid state lasers with a maximum output of 5 milliwatts. The energy is delivered through 400 micron diameter optical fiber. All four of the comparable devices deliver comparable energy density through identical or similar/comparable fiber delivery systems; therapeutic results are identical. The SiroLaser and DioDent Micro 980 are rated at 7 and 3watts (respectively) of 980nanometer laser energy. The LaserSmile and Navigator are rated at 10 and 3 watts (respectively) of 810nanometer laser energy. All comparable devices have aiming beams and similar physical specifications. All devices share similar methods of control, safety features and performance monitoring. The device complies with the performance requirements of
Performance Standards: 21 CFR 1040.10 and 1040.11, with permissible deviations relative to Laser Notice 50, Dated July 26, 2001. The device has been tested by Notified Body and are CE mark and thereby complies with other international standards including IEC 60601 and 13485 Standards.
Clinical Performance: None
Non-Clinical Performance: Tests confirm that the power densities for treatment are identical in all devices insuring that all devices provide the exact same efficacy. Similar power density and safety controls insure equivalent or superior safety performance to the comparison device. Please see attached data summary.
None requested at this time. Additional Information:
The QuickLase™DUAL Dental Laser or The Conclusions: QuickLase™810/980 Dental Laser are, in terms of Safety and Efficacy, exactly the same as the TwinWave and TidalWave devices cleared in 510(K) number K072295 and
This document including ary attachments may confidential information, privileged material or otherwise constitute non-public information by contract or law. Any use of this document and it contains by anyone other than the intended pary is prohibited. If you have received this document in eror, please immediately return I to QuickLase Limited and delete any copies from your system. Use, dissemination, distribution or reproduction of the information contained herein by unintended persons is not authorized and may be unlawful.
4
QuickLase Limited Traditional 510(K)-QuickLase™DUAL+ QuickLase™ 810/980
are only different in Brandname and certain cosmetic differences in the housings. Additionally, the QuickLase™DUAL Dental Laser or The QuickLase™810/980 Dental Laser are substantially equivalent to the listed devices without raising any issues of safety or efficacy. The device shares similar intended uses, and similar functional and performance characteristics. The device is designed to and its components have been evaluated and/or tested to comply with or exceed relevant federal safety and performance standards.
This document including any attachments may confidential information, privileged material or otherwise constitute non-public information by contract or law. Any use of this document and it contains by anyone other than the intended party is prohibited. If you have received this document in error, please imited and delete any copies from your system. Use, disemination, distribution or repoduction of the information contained herein by unintended persons is not authorized and may be vilaw[i].
5
Image /page/5/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
MAR 1 6 2010
QuickLase Limited % QuickLase - Engineering and Regulatory Consulting Mr. Calvin Ostler P.O. Box 1264, 1094 West Greasewood Drive Riverton, Utah 84065
Re: K100474 . Trade/Device Name: QuickLase™DUAL+ Dental Laser QuickLase™ (810nm) Dental Lasers
QuickLase™ (980nm) Dental Lasers 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: February 27, 2010 Received: March 09, 2010
Dear Mr. Ostler:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
6
Page 2 - Mr. Calvin Ostler
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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,
folh
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number: K100474
Device Name: QuickLase™DUAL+ Dental Laser, QuickLase™ 810 Dental Lasers, QuickLase™ 980 Dental Lasers
Indications for Use: For the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue.
| Examples: | |
|---|---|
| Excisional and incisional biopsies | Frenectomy and Frenotomy |
| Exposure of unerupted teeth | Gingival Troughing for crown impressions |
| Fibroma removal | Gingivectomy |
| Gingivoplasty | Ginigival incision and excision |
| Hemostasis and coagulation | Implant Recovery |
| Incision and drainage of abscess | Leukoplakia |
| Operculectomy | Oral papillectomies |
| Pulpotomy | Pulpotomy as an adjunct to root canal therapy |
| Reduction of gingival hypertrophy | Reduction of bacterial level (decontamination) and inflammation |
| Soft Tissue crown lengthening | Treatment of aphthous ulcers |
| Vestibuloplasty | Lesion (tumor) removal |
| Laser Soft Tissue Curettage | Treatment of canker sores, herpetic and other ulcers of the oral mucosa |
| Tissue Retraction |
Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithlium
Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility Light activation of bleaching materials for teeth whitening
Laser-assisted whitening/bleaching of teeth
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Explus Division of Surgical, Orthopedic, and Restorative Devic Page 1 of 1 This document including any attachments may confidential information, privileged material or otherwise constitute non-publi
information by contract or law. Any use of this document and it contains by anyone other than the intended party is prohibiled. If you have received this document in error, please imited and delete any copies from your system. Use, dissenination distribution, or reproduction of the information contained herein by unintended persons is not authorized and may be unlawful