(152 days)
Not Found
No
The device description focuses on hardware components, laser modes, and user interface for setting parameters. There is no mention of AI, ML, or any algorithms that learn or adapt. The performance studies compare laser output accuracy, not algorithmic performance.
Yes
The device is designed to treat various soft tissue conditions and perform surgical procedures, which directly aligns with the definition of a therapeutic device.
No
The device is intended for ablating, incising, vaporizing, and coagulation of soft tissues, which are therapeutic procedures, not diagnostic ones.
No
The device description clearly outlines hardware components including a control box, laser handpiece, fiber optic components, disposable tips, power supply, and battery. While it has a microprocessor and user interface, it is fundamentally a hardware device with integrated software for control.
Based on the provided information, the VIAX Dental Lab LUCERNA VDL980-1 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for use in dental intraoral soft tissue, general, oral maxillafacial and cosmetic surgery for procedures like ablating, incising, vaporizing, and coagulation of soft tissues. These are all procedures performed on the patient's body, not on samples taken from the body.
- Device Description: The description details a laser device with different modes for surgical procedures, curing dental materials, and whitening teeth. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any analysis of biological specimens (blood, tissue, etc.) or any diagnostic purpose. IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, the VIAX Dental Lab LUCERNA VDL980-1 is a surgical laser device used for therapeutic and cosmetic procedures, not an IVD.
N/A
Intended Use / Indications for Use
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxillafacial and cosmetic surgery. It is intended for ablating, incising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed:
- . Excision and incision biopsies
- . Hemostatic assistance
-Treatment of apthous ulcers - . Frenectomy
- . Frenotomy
- . Gingival incision and excision
- . Gingivectomy
- . Gingivoplasty
- . Incising and draining abscesses
- . Operculectomy
- . Oral papillectomy
- . Removal of fibromas
- . Soft tissue crown lengthening
- . Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
- . Tissue retraction for impression
- . Photo initiation of gingival barriers and dams
- . Laser-assisted bleaching/whitening of teeth
Product codes
GEX
Device Description
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser is comprised of three basic parts: The control box ("control module") with microprocessor and user interface for selection of modes: (a) Procedural (continuous wave or pulsed) 980mm laser output (b) Curing (dental photo initiated materials) at 450mm (+/-10mm) with timed outputs of 1.3, and 5 second(s) of output duration; and (c) Whitening procedures at 450nm (+/-10nm) timed to provide 15 minute durational output(s); A touch screen LCD display to provide visual indications of power settings and of the unit"s status, and accept inputs via the touch screen to select modes and operational parameters and adjust / set and features the units power ON/OFF functions, Application of user PIN number for operation and initialization, Selection of Language (English, Spanish, Portugese) and System settings (PIN/Password setting); the Second component is the laser handpiece that houses the laser working beam and aiming beam fiber optic component(s) and the disposable fiberoptic tip assemblies (Procedural, Curing, and Whitening). Two optional footswitches are available that can be used to activate the laser working beam: (a) Corded that plugs into the back of the system unit and (optional) wireless footswitch. Electrical power is taken from the AC/DC 12 vdc Power Supply that plugs into a standard electrical outlet and charges the L-ion 7.2VDC battery at 24W, a 7,2 VDC lithium-ion battery that generates 4 amps used to drive the diode laser(s) and system overhead.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dental intraoral soft tissue
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)
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser has been tested side-by-side against one of the predicate devices. Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the VIAX Dental Lab LUCERNA VDL980-1 settings by an average of only 1.4% in CW and 0.5% in P(ulse) compared to the predicate's variance of 2.2% in CW and 2.7% in P(ulse). The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device"s setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard.
The Viax Dental Lab Lucerna VDL980-1 has been tested and is in compliance with IEC60601-1 (Medical Electrical Equipment Safety); IEC60601-1-2 (EMC): IEC60825-1/IEC60601-2-22 (Photobiological Safety); Software validation in compliance with IEC61508; and ISO 14971 (Risk Management).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or progress. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 26, 2016
Viax Dental Lab Mr. Edwin First Regulatory Affairs Consultant Calle Potrerillos, Flexipark Bodegas D2 Alajuela, San Rafael Cost Rica 20108
Re: K161185 Trade/Device Name: VIAX Dental Lab LUCERNA VDL 980-1 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: August 24, 2016 Received: August 24, 2016
Dear Mr. First:
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 Part 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 Parts 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 yours,
Christopher J. Ronk -S
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
Indications for Use
510(k) Number (if known) K161185
Device Name
VIAX Dental Lab LUCERNA VDL980-1
Indications for Use (Describe)
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxillafacial and cosmetic surgery. It is intended for ablating, incising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed:
- . Excision and incision biopsies
- . Hemostatic assistance
- .Treatment of apthous ulcers
- . Frenectomy
- . Frenotomy
- . Gingival incision and excision
- . Gingivectomy
- . Gingivoplasty
- . Incising and draining abscesses
- . Operculectomy
- . Oral papillectomy
- . Removal of fibromas
- . Soft tissue crown lengthening
- . Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket)
- . Tissue retraction for impression
- . Photo initiation of gingival barriers and dams
- . Laser-assisted bleaching/whitening of teeth
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary of Safety and Effectiveness
VIAX Dental Lab VIAX DENTAL LAB LUCERNA VDL980-1
Submitted for: Viax Dental Lab,
| Phone: | 949-633-3554 |
|---|---|
| Facsimile: | (888) 557-7207 |
| Contact Person: | Edwin First |
| Date Prepared: | 20 April 2016 |
Device Proprietary Name(s): VIAX DENTAL LAB LUCERNA VDL980-1 Dental Laser Common or Usual Name: General Dental Use Soft tissue and Curing Laser Product Classification: Powered Laser Surgical Instrument Product Code: GEX Predicate Device(s): (1) Biolase EPIC soft tissue Laser (2) ILT Systems ACL 5500 Argon Curing Laser(3) Denmat Sapphire ST Portable
Rationale for Substantial Equivalence
Both the subject and predicate devices share similar intended uses and indications for use, technical characteristics, features, and specifications. The Laser characteristics of the VIAX Dental Lab LUCERNA VDL980-1. including working wavelengths and outputs, Light delivery methods, safety features, and performance specifications are similar to those of the cleared Biolase Epic, ILT ACL5500, and Denmat Sapphire ST Portable Dental Lasers. The VIAX Dental Lab LUCERNA VDL980-1 operating system and controls of the subject device are similar to those used by the previouslycleared predicate devices that have proven safety and effectiveness records in the treatment of the claimed indications. Safety and performance test results have been shown to satisfy applicable international standards recognized by the Agency.
Intended Uses and Indications for Use
The VIAX Dental Lab LUCERNA VDL980-1 is intended for use in dental intraoral soft tissue, general, oral maxilla-facial and cosmetic surgery. It is intended for ablating, incising, excising, vaporizing and coagulation of soft tissues using a fiber optic delivery system. The following are the indications for which the device will be marketed:
- Excision and incision biopsies
- Hemostatic assistance ●
- Treatment of apthous ulcers ●
- Frenectomy ●
4
- Frenotomy ●
- Gingival incision and excision ●
- Gingivectomy
- Gingivoplasty ●
- Incising and draining abscesses
- Operculectomy
- Oral papillectomy
- . Removal of fibromas
- Soft tissue crown lengthening ●
- Sulcular debridement (removal of diseased or inflamed soft tissue in the ● periodontal pocket)
- Tissue retraction for impression
- Photo initiation of gingival barriers and dams
- Laser-assisted bleaching/whitening of teeth ●
Device Description
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser is comprised of three basic parts: The control box ("control module") with microprocessor and user interface for selection of modes: (a) Procedural (continuous wave or pulsed) 980mm laser output (b) Curing (dental photo initiated materials) at 450mm (+/-10mm) with timed outputs of 1.3, and 5 second(s) of output duration; and (c) Whitening procedures at 450nm (+/-10nm) timed to provide 15 minute durational output(s); A touch screen LCD display to provide visual indications of power settings and of the unit"s status, and accept inputs via the touch screen to select modes and operational parameters and adjust / set and features the units power ON/OFF functions, Application of user PIN number for operation and initialization, Selection of Language (English, Spanish, Portugese) and System settings (PIN/Password setting); the Second component is the laser handpiece that houses the laser working beam and aiming beam fiber optic component(s) and the disposable fiberoptic tip assemblies (Procedural, Curing, and Whitening). Two optional footswitches are available that can be used to activate the laser working beam: (a) Corded that plugs into the back of the system unit and (optional) wireless footswitch. Electrical power is taken from the AC/DC 12 vdc Power Supply that plugs into a standard electrical outlet and charges the L-ion 7.2VDC battery at 24W, a 7,2 VDC lithium-ion battery that generates 4 amps used to drive the diode laser(s) and system overhead.
Conformity to International Standards
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser complies with the performance requirements listed in 21 CFR 1040.10 and 1040.11, with permissible deviations pursuant to Laser Notice 50, dated July 26, 2001. Additionally, the subject device has been shown to conform to the same international electrical safety standards for electrical medical devices in general, and lasers in particular, as the predicate devices: IEC 60601-1, IEC 60601-2-2, IEC 60825-1, and IEC 60601-2-22.
Comparative Performance Data
5
The VIAX Dental Lab LUCERNA VDL980-1 Portable Diode Laser has been tested side-by-side against one of the predicate devices. Measurements of the output of the subject device's working beam ranging from 0.1 to 3.0W output in Continuous Wave and Pulse modes were shown to vary from the VIAX Dental Lab LUCERNA VDL980-1 settings by an average of only 1.4% in CW and 0.5% in P(ulse) compared to the predicate's variance of 2.2% in CW and 2.7% in P(ulse). The intended performance of these devices, based on IEC 60601-2-22, is that laser output should vary from the device"s setting by less than ± 20% of the setting. Both the subject and predicate devices have been shown to satisfy this standard.
Comparison of Features and Characteristics
Table 1, following, lists key Features and Characteristics of the subject and three predicate devices.
Table 1.
| | VIAX Dental Lab
VIAX Dental Lab
LUCERNA
VDL980-1 | Biolase
EPIC Portable
Dental Laser | ILT
ACL5500
Dental Curing
Laser | Denmat Holdings
Sapphire ST
Portable Laser |
|-----------------------|----------------------------------------------------------------------------------------------------|-------------------------------------------------|------------------------------------------|----------------------------------------------------------------------------------------------------|
| Application | Dental Laser
(Multi Function) | Dental Laser
(Multi Function) | Curing Laser | Dental Laser |
| Wavelength | $980nm \pm 10nm$ | $980 \pm 5 nm$ | $450 \pm 20 nm$ | $808 \pm 5 nm$ |
| Power | 0.1 - 3.0 W (CW)
0.1 - 5.0 W (Pulse) | 0.1 - 3.0 W (CW)
0.1 - 5.0 W (Pulse) | 500mW | 0.1 - 3.0 W (CW)
0.1 - 5.0 W (Pulse) |
| Aiming
Beam | 640 nm
(±10nm),
maximum
2mW
(adjustable) | 640 nm (±10 nm),
maximum 2mW
(adjustable) | N/A | 640 nm (±10 nm),
maximum 2mW
(adjustable) |
| Cooling
System | Convection cooled | Convection cooled | FAN forced air | Convection Cooled |
| Pulse
Control | Digital
emission
Contr
ol | Digital emission
control | N/A | Digital emission
control |
| Laser
Source | Solid-state diode | Solid-state diode | Argon Ion | Solid State Diode |
| Power
Requirements | 24W 12VDC
supplied from 110 -
120 VAC @ 60 Hz
or 220 - 240 VAC
@ 50 Hz
(switchable) | | 100-240VAC @ 50-
60 Hz, (switchable) | 24W 12VDC
supplied from 110 -
120 VAC @ 60 Hz or
220 - 240 VAC
@ 50 Hz
(switchable) |
| User
Interface | LCD Touch Screen
Interface | LCD Touch Screen
Interface | Discreet switches | Membrane touch
pad,LED indicators |
6
| Fiberoptic
Tip | Disposable, 200 µm unit
dose | Disposable, 200µm
unit dose | Optic/mirror via
400um fiber
optic | Disposable, 400 µm unit dose |
|-------------------|---------------------------------|--------------------------------|------------------------------------------|-------------------------------|
| Sterility | Disposable, Barrier
sleeve | Disposable, Barrier
sleeve | Disposable, Barrier
sleeve | Disposable, Barrier
sleeve |
| 510(k)
Number | Pending this
application | K140120 | K930210 | K103667 |
Conclusion
The subject device shares the same principle of operation as the three predicate devices. All are diode lasers that emit radiant energy at approximately 808nm to 980mm and 450nm with outputs that range from 0.1 to 5.0W. All deliver collimated laser energy to subject target tissue via 200 to 400 um fiberoptic tips controlled by trained, experienced clinicians. All share the same indications for use in dental intraoral soft tissue general, oral maxilla-facial and cosmetic surgery. All have photo initiated dental teeth whitening, and one other has dental materials curing. All have been found to satisfy international safety standards relating to electrical medical devices in general and medical lasers in particular. All have similar safety labeling, device interlocks, and associated safety features. Both the subject and a predicate devices output were measured and compared to their settings to determine the accuracy of the devices" controls. Both met international standards pertaining to accuracy of output of the working beam, but the difference between the subject devices output and its setting was much less than the predicate's, demonstrating not only conformance to the standard, but also superior control over laser emissions. Performance testing has been accomplished for the Viax Dental Lab Lucerna VDL980-1that compares it to the predicate devices and that it meets international standards pertinent to validating its performance and compliance. The Viax Dental Lab Lucerna VDL980-1 has been tested and is in compliance with IEC60601-1 (Medical Electrical Equipment Safety); IEC60601-1-2 (EMC): IEC60825-1/IEC60601-2-22 (Photobiological Safety); Software validation in compliance with IEC61508; and ISO 14971 (Risk Management).
The VIAX Dental Lab LUCERNA VDL980-1
Viax Dental Lab Lucerna VDL980-1 device shares intended uses, principle of operation, technical attributes, functional capabilities, and performance characteristics with the listed predicate devices. Both the subject and predicate devices have been shown to comply with applicable Federal and international safety and performance standards. The Sapphire ST Portable Laser is substantially equivalent to the listed predicate laser surgical devices and does not raise any issues of safety or effectiveness.