(275 days)
No
The device description focuses on the hardware components (laser diodes, fiber optic tip, microprocessor for control) and safety standards. There is no mention of AI, ML, or any data processing that would suggest the use of such technologies. The "main control with microprocessor" is typical for basic device operation and does not imply AI/ML.
Yes
The device's intended uses clearly describe procedures for treating various dental conditions and improving clinical health, which aligns with the definition of a therapeutic device.
No
This device is a surgical laser system designed for various dental soft tissue procedures, not for diagnosis. Its intended uses involve incision, vaporization, ablation, and coagulation of tissues.
No
The device description clearly outlines a hardware system including a laser handpiece, laser diodes, fiber optic tip, charging stand, and other physical components. While it mentions control circuitry with a microprocessor and user interface, this is part of the hardware system controlling the laser, not a standalone software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The Ultrafast series of dental lasers are used for surgical procedures directly on the patient's oral soft tissues and within the periodontal pocket. They are used for cutting, vaporizing, ablating, and coagulating tissue. This is a direct treatment or intervention, not a diagnostic test performed on a sample.
- Intended Use: The listed intended uses are all surgical procedures performed directly on the patient.
- Device Description: The description details a laser system designed to deliver energy to tissue, not to analyze biological samples.
Therefore, based on the provided information, the Ultrafast series of dental lasers are therapeutic devices used for surgical procedures, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following:
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Frenectomy and frenotomy
- · Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- · Pulpotomy
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and ulcers
- · Vestibuloplasty
- · Tissue retraction for impression
Laser periodontal indications including:
· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.
Product codes (comma separated list FDA assigned to the subject device)
NVK, GEX
Device Description
The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip.
The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery.
Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:
| Trade Name | Wavelength (nm) | Max CW Power (Watt) |
|---|---|---|
| Ultrafast | 808 | 3 |
| Ultrafast Plus | 980 | 3 |
| Ultrafast Lite | 808 | 1.5 |
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft tissues, periodontal pocket
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 subject devices have been tested for optical, thermal, electrical and mechanical safety and comply with the electrical and optical safety requirements as the predicate devices: IEC 6060-1, IEC 60601-1-2, IEC 60825-1 and IEC 60601-2-22.
The subject devices have been tested for biocompatibility and comply with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The subject devices have tested and verified to meet all design specifications that are substantially equivalent to the predicate devices.
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.
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/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 26, 2021
DentLight Inc. Richard Liu President 1825 Summit Ave. Ste 210 Plano, Texas 75074
Re: K201387
Trade/Device Name: Ultrafast, Ultrafast Plus, Ultrafast Lite 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: NVK, GEX Dated: February 9, 2021 Received: February 12, 2021
Dear Richard Liu:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael Adjodha Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
III. Indications for Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201387
Device Name
Ultrafast/Ultrafast Plus/Ultrafast Lite
Indications for Use (Describe)
Dental soft tissue indications: incision, vaporization, ablation, and coagulation of oral soft tissues including the following:
- · Gingival troughing for crown impression
- · Gingivectomy
- · Gingivoplasty
- · Gingival incision and excision
- · Hemostasis and coagulation
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- · Fibroma removal
- · Frenectomy and frenotomy
- · Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
- · Operculectomy
- · Oral papillectomies
- · Pulpotomy
- · Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and ulcers
- · Vestibuloplasty
- · Tissue retraction for impression
Laser periodontal indications including:
· Sulcular debridernent (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including: gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
CONTINUE ON A SEPARATE PAGE IF NEEDED.
3
IV. 510(k) Summary
K201387
This summary of 510(k) substantial equivalence is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. APPLICANT
DentLight Inc. 1825 Summit Ave., Suite 210 Plano, TX 75074
Phone: 972-889-8857 Fax: 972-346-6550 Contact Person: Richard Liu Date Prepared: Feb. 8, 2021
2. DEVICE NAME
Proprietary Name: Ultrafast/Ultrafast Plus/Ultrafast Lite
Common/Usual Name: Dental Diode Laser
Classification Name: Laser Surgical Instrument for Use in General and Plastic Surgery and in Dermatology (878.4810)
Product Code: GEX
3. PRIMARY PREDICATE DEVICE
Styla Microlaser (K081214), manufactured by Zap Lasers, LLC.
REFERENCE DEVICE
K2 Mobile (K200693), manufactured by Hu Laser.
4. INTENDED USE / INDICATIONS FOR USE
Dental soft tissue indications: incision, excision, vaporization, and coagulation of oral soft tissues including the following:
- Gingival troughing for crown impression
- · Gingivectomy
- Gingivoplasty
- · Gingival incision and excision
- Hemostasis and coagulation
- · Excisional and incisional biopsies
- Exposure of unerupted teeth
- Fibroma removal
- Frenectomy and frenotomy
- Implant recovery
- · Incision and drainage of abscess
- · Leukoplakia
4
- Operculectomy
- · Oral papillectomies
- · Pulpotomy
- Pulpotomy as an adjunct to root canal therapy
- · Reduction of gingival hypertrophy
- · Soft tissue crown lengthening
- · Treatment of canker sores, herpetic and ulcers
- · Vestibuloplasty
- · Tissue retraction for impression
Laser periodontal indications including:
· Sulcular debridement (curettage, removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival bleeding index, probe depth, attachment loss, and tooth mobility).
· Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket.
5. DEVICE DESCRIPTION
The Ultrafast series (Ultrafast, Ultrafast Plus, and Ultrafast Lite) are cordless diode laser systems designed for a wide variety of dental soft tissue procedures. The products have three separate models under the model names: Ultrafast, Ultrafast Plus and Ultrafast Lite. They use solid-state laser diodes as sources of infrared radiation. The energy from the infrared radiation is delivered to the treatment site via a single-use fiber optic tip.
The product kit consists of a laser handpiece, laser goggles, charging stand, power adapter, laser shield, barrier sleeves, product warning labels and instructions for use. The laser handpiece is constructed from anodized aluminum and contains a single-use, disposable fiber optic tip and main body containing laser diode, main control and a rechargeable battery assembly. The main control houses the control circuitry with microprocessor and user interface to control and deliver the laser and a green aiming beam to guide the laser procedures. The charging stand allows for the placement of the handpiece in a holder with electrical connection to the power adapter as the source for charging the rechargeable battery.
Based on the wavelength and power of the laser diodes used, the kit can be preconfigured into three separate models:
| Trade Name | Wavelength (nm) | Max CW Power (Watt) |
|---|---|---|
| Ultrafast | 808 | 3 |
| Ultrafast Plus | 980 | 3 |
| Ultrafast Lite | 808 | 1.5 |
6. DEVICE CHARACTERISTICS AND SUBSTANDTIAL EQUIVALENCE
Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the primary predicate device Styla Microlaser (K081214), manufactured by Zap Lasers, LLC (now Denmat) and the reference device K2 Mobile (K200693), manufactured by Hu Laser. A comparison table on performance and technology with the predicate and reference devices lists key features and characteristics of the subject and predicate devices. It shows the subject products have technology characteristics as the predicate devices.
5
Subject Device Performance and Technological Comparison
| Parameter\ Name | Ultrafast / Ultrafast Plus /Ultrafast Lite | Styla Microlaser (Primary Predicate Device) | K2 MOBILE (Reference Device) | |
|---|---|---|---|---|
| Manufacturer | DentLight | Zap Laser/Denmat | Hu Laser | |
| 510(k) Number | K201387 | K081214 | K200693 | |
| Light Source | Diode Laser | Diode Laser | Diode Laser | |
| Regulation Number | 878.4810 | 878.4810 | 878.4810 | |
| Device Class | II | II | II | |
| Product Code | GEX | GEX | GEX | |
| Peak Wavelength | 808±10 nm (Ultrafast/Ultrafast Lite) | |||
| 980±10 nm (Ultrafast Plus) | 808±5 nm | 980±10 nm | ||
| Maximum CW Power | ||||
| (Watt) | 3 (Ultrafast/Ultrafast Plus) | |||
| 1.5 (Ultrafast Lite) | 1.5 | 3.5 | ||
| Maximum Pulse Power | ||||
| (Watt) | 5 (Ultrafast/Ultrafast Plus) | |||
| 2 (Ultrafast Lite) | 2 | 6 | ||
| Power Accuracy (W) | ±20% | ±20% | ±20% | |
| Fiber Core Diameter | ||||
| (μm) | 400 | 400 | 400 | |
| Aiming Beam | 525 (±10nm, 0.6mW) | 650 (±10nm, 0.5mW) | 635 (5 mW) | |
| OPERATION | ||||
| MODE | Continuous / Pulse | Continuous / Pulse | Continuous / Pulse | |
| Display | LCD | OLED | OLED | |
| Audible Notification | Yes | Yes | Yes | |
| Visual Notification | Yes | Yes | Yes | |
| Length | ||||
| (without fiber tip) | 163 | 175 | 205 | |
| Weight | Handpiece | 100 | 55 | 135 |
| (grams) | Charging | |||
| Stand | 88 | 340 | 150 | |
| Battery | Lithium ion | Lithium ion | Lithium ion | |
| Power Supply Input | 100-240V, 50/60Hz | Input: 100-240V, 50-60Hz | Input: 100-240V, 50-60Hz | |
| Structure | Ergonomic aluminum wand | Ergonomic aluminum wand | Ergonomic aluminum/plastic wand | |
| Compliance Standards | IEC 60601-1; IEC 60601-1-2; IEC | |||
| 60825-1; IEC 60601-2-22 | IEC 60601-1; IEC 60825-1; | |||
| IEC 60601-2-22 | IEC 60601-1; IEC 60825-1; IEC | |||
| 60601-2-22 |
Subject Device Indications for Use Comparisons
| Parameter Name | Ultrafast / Ultrafast Plus
/Ultrafast Lite | Styla Microlaser
(Primary Predicate Device) | K2 MOBILE
(Reference Device) |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | DentLight | Zap Laser/Denmat | Hu Laser |
| 510(k) Number | K201387 | K081214 | K200693 |
| Indications for Use | Dental soft tissue indications:
incision, excision, vaporization,
ablation, and coagulation of oral
soft tissues including the
following:
• Gingival troughing for crown
impression
• Gingivectomy
• Gingivoplasty
• Gingival incision and excision
• Hemostasis and coagulation
• Excisional and incisional | Intended for ablating,
incising, excising,
vaporizing, and coagulation
of oral soft tissues using a
contact fiber optic delivery
system. The following are the
oralpharngeal indications for
use for which the device will
be marketed:
• Excisional and incisional
biopsies
• Hemostasis assistance | Intended for use by dentists
for excision, incision,
vaporization, ablation and
coagulation of oral soft tissue
procedures, including Tooth
Whitening and the temporary
relief of pain. The Specific
indications are as follows:
• Biopsies
• Crown lengthening
• Exposure of unerupted teeth
• Fibroma removal |
DentLight Inc. 510(k) - K201387 Feb. 8, 2021
6
| biopsies | • Treatment of aphthous
ulcers | • Frenectomy |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| • Exposure of unerupted teeth | • Frenectomy and frenotomy | • Gingival troughing |
| • Fibroma removal | • Gingival Incision and
Excision | • Gingivectomy |
| • Frenectomy and frenotomy | • Gingivectomy | • Gingivoplasty |
| • Implant recovery | • Gingivoplasty | • Pulpotomy |
| • Incision and drainage of abscess | • Incision and drainage of
abscess | • Root canal therapy |
| • Leukoplakia | • Operculectomy | • Hemostasis and coagulation |
| • Operculectomy | • Oral papillectomy | • Leukoplakia |
| • Oral papillectomies | • Removal of fibromas | • Implant recovery |
| • Pulpotomy | • Soft tissue crown
lengthening | • Incision and drainage of
abscess |
| • Pulpotomy as an adjunct to root
canal therapy | • Sulcular debridement
(removal of diseased or
inflamed soft tissue in the
periodontal pocket) | • Operculectomy |
| • Reduction of gingival
hypertrophy | • Vestibuloplasty | • Papillectomies |
| • Soft tissue crown lengthening | | • Reduction of gingival
hypertrophy |
| • Treatment of canker sores,
herpetic and aphthous ulcers | | • Treatment of Aphthous-
ulcer canker sores and
herpetic |
| • Vestibuloplasty | | •Vestibuloplasty |
| • Tissue retraction for impression | | |
| Laser periodontal indications
including: | | Periodontal procedures: |
| • Sulcular debridement (curettage,
removal of diseased, infected,
inflamed and necrosed soft tissue
in the periodontal pocket to
improve clinical indices including
gingival index, gingival bleeding
index, probe depth, attachment
loss, and tooth mobility). | | • Sulcular debridement |
| • Laser removal of diseased,
infected, inflamed and necrosed
soft tissue within the periodontal
pocket. | | • Topical heating for the
purpose of elevating tissue
temperature for temporary
relief of minor muscle
and joint pain and stiffness
minor arthritis pain, or
muscle spasm, minor sprains
and minor muscular back
pain; the temporary increase
in local blood circulation; the
temporary relation of muscle |
| | | • Laser Assisted whitening |
Similarities between Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices:
- · Ultrafast/Ultrafast Plus/Ultrafast Lite have the same indications for use as the predicate/reference devices.
- · Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent operating modes as the predicate/reference devices.
- · Ultrafast/Ultrafast Plus/Ultrafast Lite have substantially equivalent design, construction materials, weight, size, performance characteristics and key features as the predicate/reference devices.
- · Ultrafast/Ultrafast Plus/Ultrafast Lite are substantially equivalent to the predicate/reference devices in standards compliance.
Differences between the Ultrafast Plus/Ultrafast Lite and Predicate/Reference Devices:
Ultrafast/Ultrafast Plus/Ultrafast Lite have an LCD display instead of an OLED display by the predicate and reference devices. They use green aiming beams instead of red aiming beams by the predicate and reference devices. The difference in display and aiming beam improves the operator's ease of use and does not raise any substantial equivalence concerns as it has similar performance of the predicate and reference devices. The device modifications do not potentially alter the fundamental scientific technology of the device.
7. NON-CLINICAL PERFORMANCE TESTING
The subject devices have been tested for optical, thermal, electrical and mechanical safety and comply with the electrical and optical safety requirements as the predicate devices: IEC 6060-1, IEC 60601-1-2, IEC 60825-1 and IEC 60601-2-22.
7
The subject devices have been tested for biocompatibility and comply with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process. The subject devices have tested and verified to meet all design specifications that are substantially equivalent to the predicate devices.
8. CONCLUSION
Based on similarities in indications for use and technology together with results from performance testing, we believe that Ultrafast Plus/Ultrafast Lite Diode Lasers are substantially equivalent to the predicate devices.