(90 days)
Not Found
No
The document describes a laser device for dental and pain therapy applications. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies summary.
Yes
The device description explicitly states, "The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain."
No.
The device is described as a "surgical and therapeutic device" used for various "oral soft-tissue procedures," "dental whitening," and "temporary relief of minor pain." Its functions include incision, excision, vaporization, and ablation, which are all treatment-oriented actions rather than diagnostic ones.
No
The device description explicitly states it is a "surgical and therapeutic device" that uses a "solid-state laser diode" and includes hardware components like a "base console," "wireless footswitch," "fiber optic cable," and "handpiece." This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications are all related to surgical and therapeutic procedures performed directly on the patient's body. These include cutting, removing, treating, and activating tissues and materials within the oral cavity and for pain relief. IVDs, on the other hand, are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information about a person's health status.
- Device Description: The description clearly states it's a surgical and therapeutic device that emits laser energy to a treatment site on the patient. This aligns with a device used for direct patient intervention, not for analyzing samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or providing diagnostic information based on laboratory testing.
Therefore, the Epic 980 diode laser, as described, is a medical device used for direct treatment and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- Fibroma removal
- · Frenectomy
- · Frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival 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
- · Soft-tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
- · Tissue retraction for impression
- · Laser soft-tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
· Sulcular debridement (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)
-
· Reduction of bacterial level (decontamination) and inflammation
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium -
· Lesion (tumor) removal
-
· Removal of hyperplastic tissues
-
· Laser assisted flap surgery
-
· Removal of granulation tissue
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
Pain Therapy
· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral soft-tissues, teeth, muscle, joint
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 and Bench Testing
Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required.
Biocompatibility and Sterilization Testing
No new biocompatibility and sterilization testing were performed. All patient-contacting accessories remain the same as previously cleared under K192430.
Electrical Safety and Electromagnetic Compatibility (EMC)
All relevant electrical safety and EMC testing have been conducted in accordance with current recognized standards. The Epic 980 diode laser complies with the requirements.
IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2- electromagnetic compatibility (EMC)
IEC 60601-1:2012
Medical electrical equipment - Part 1: general requirements for basic safety and essential performance
IEC 60601-2-22:2007+ A1:2012
Medical electrical equipment- Part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014
Safety of laser products- Part 1: equipment classification and requirements
IEC 80601-2-60:2012
Medical electrical equipment - Part 2-60: particular requirements for the basic safety and essential performance of dental equipment
Software Verification and Validation
Software contained in Epic 980 was developed, tested and documented in accordance with IEC 62304:2015 – Medical Device Software - Software Lifecycle and the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". Verification and validation testing demonstrate performance according to specifications and functions intended.
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.
Epic 980 (K192430), QuickLase 980, 810 & Dual (K100474), SIROLase Advance (K103753), Elumi 810+980 (K152032), Curative980 Diode Laser (K082445)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Biolase, Inc Alicia Mszyca Director, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K193486
Trade/Device Name: Epic 980 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: December 13, 2019 Received: December 17, 2019
Dear Alicia Mszyca:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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,
Jessica Mavadia-Shukla, Ph.D. Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193486
Device Name Epic 980
Indications for Use (Describe)
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- · Excisional and incisional biopsies
- · Exposure of unerupted teeth
- Fibroma removal
- · Frenectomy
- · Frenotomy
- · Gingival troughing for crown impressions
- · Gingivectomy
- · Gingivoplasty
- · Gingival 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
- · Soft-tissue crown lengthening
- · Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- · Vestibuloplasty
- · Tissue retraction for impression
- · Laser soft-tissue curettage
- · Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
· Sulcular debridement (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)
-
· Reduction of bacterial level (decontamination) and inflammation
• Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium -
· Lesion (tumor) removal
-
· Removal of hyperplastic tissues
-
· Laser assisted flap surgery
-
· Removal of granulation tissue
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
3
Pain Therapy
· Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary increase in local blood circulation; the temporary relaxation of muscle.
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) |
|---|---|
| ---------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------- |
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4
Image /page/4/Picture/1 description: The image shows the word "BIOLASE" in a bold, sans-serif font. The word is all capitalized and is a dark blue color. The background is white, which makes the word stand out.
510(k) SUMMARY
I. SUBMITTER
Biolase, Inc. 4 Cromwell Irvine, CA 92618 USA Tel: (949) 226-8471 Fax: (949) 273-6688 Contact Person: Alicia Mszyca Date Prepared: December 13, 2019
II. DEVICE
| Name of Device: | Epic 980 |
|---|---|
| Common Name: | Dental Diode Laser |
| Classification Name: | Laser surgical instrument for use in general and plastic surgery and |
| in dermatology (21 CFR 878.4810) | |
| Device Class: | II |
| Product Code: | GEX |
III. PREDICATE DEVICES
Epic 980 (K192430) QuickLase 980, 810 & Dual (K100474) SIROLase Advance (K103753) Elumi 810+980 (K152032) Curative980 Diode Laser (K082445)
IV. DEVICE DESCRIPTION
The Epic 980 diode laser is a surgical and therapeutic device designated for a wide variety of oral soft-tissue procedures and dental whitening as well as for use in providing a temporary relief of minor pain.
The device uses a solid-state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a handpiece that emits the energy to the treatment site.
The laser is comprised of a base console, a wireless footswitch which activates the laser and a detachable delivery system consisting of a fiber optic cable, surgical handpiece and single-use disposable tips designed and optimized for different applications.
5
V. INDICATIONS FOR USE STATEMENT
Dental Soft Tissue Indications
Incision, excision, vaporization, ablation and coagulation of oral soft-tissues including marginal and inter-dental gingival and epithelial lining of free gingiva and the following specific indications:
- Excisional and incisional biopsies
- Exposure of unerupted teeth ●
- Fibroma removal ●
- Frenectomy
- Frenotomv
- Gingival troughing for crown impressions ●
- Gingivectomy
- Gingivoplasty
- Gingival 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
- Soft-tissue crown lengthening
- . Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa
- Vestibuloplasty
- Tissue retraction for impression
- Laser soft-tissue curettage
- Laser removal of diseased, inflamed and necrosed soft-tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, 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)
- Reduction of bacterial level (decontamination) and inflammation ●
- Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium
- Lesion (tumor) removal
- Removal of hyperplastic tissues ●
- Laser assisted flap surgery
- Removal of granulation tissue
6
Image /page/6/Picture/0 description: The image shows the word "BIOLASE" in all capital letters. The word is written in a bold, sans-serif font. The color of the text is a dark blue.
Whitening
- · Light activation for bleaching materials for teeth whitening
- · Laser-assisted whitening/bleaching of teeth
Pain Therapy
- · Topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, minor sprains and strains, and minor muscular back pain; the temporary
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS VI.
The Epic 980 subject device is the same as Epic 980 (K192430) except for the expanded indications for use already cleared for devices: Ouicklase 810, 980, Dual + (K100474) by QuickLase Limited, SIROLaser Advance (K103753) by Sirona, Elumi 810 + 980 (K152032) by Azena Medical, LLC and Curative980 (K082445) by OroScience, Inc.
The Epic 980 shares the same technological characteristic as the predicate devices including:
- the same laser source: solid state diode producing invisible infrared energy
- the same wavelength: 980nm
- the same intended use: incision, excision, vaporization, ablation and coagulation of ● oral soft tissue
- the same indications for use
- . the same patient-contacting components: glass fiber used in contact and non-contact mode the same use environment
- the same tissue type and application regimen
- the same principle of operation and emission mode: continuous wave, pulsed or . both the same control mechanism
- similar design consisting of software-operated portable laser unit, initiated by a ● footswitch similar delivery system comprising of an optical fiber, handpiece and single use disposable tips
- . the same human factors of user interface
Although some parameters such as maximum power output, power density, pulse rate differ among the devices, these differences do not result is a significantly different clinical performance since the settings and used for the expanded indications as well as the treatment regimen are essentially the same. Therefore, the consolidation of clinical applications creates no new risks or safety concerns.
7
Companson of the technological characteristics, intended use, indications for use of the Epic 980 subject and predicate devices:
| Subject Device | Predicate Devices | Reference Device | Pulse duration | 0.01 - 20 ms | 0.01 - 20 ms | 50, 30, 10ms | 0.01 – 0.99 s | variable | unknown | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Specification | Biolase Inc. | ||||||||||||
| Epic 980 | Biolase, Inc. | ||||||||||||
| Epic 980 | |||||||||||||
| (K192430) | QuickLase Limited | ||||||||||||
| QuickLase 980, 810 | |||||||||||||
| and Dual+ | |||||||||||||
| (K100474) | Sirona | ||||||||||||
| SIROLaser Advance | |||||||||||||
| (K103753) | Azena Medical, | ||||||||||||
| LLC | |||||||||||||
| Elumi 810 + 980 | |||||||||||||
| (K152032) | OroScience, Inc. | ||||||||||||
| Curative980 Diode | |||||||||||||
| Laser (K082445) | Spot size tips | 200 – 400 μm | 200 – 400 μm | 400 μm | 200 - 320 μm | 400 μm | unknown | ||||||
| Laser medium | Solid state diode | ||||||||||||
| laser | Solid state diode | ||||||||||||
| laser | Solid state diode | ||||||||||||
| laser | Solid state diode | ||||||||||||
| laser | Solid state diode | ||||||||||||
| laser | Solid state diode | ||||||||||||
| laser | Power density | Up to | |||||||||||
| 28294W/cm² | Up to | ||||||||||||
| 28294W/cm² | Up to | ||||||||||||
| 15915W/cm² | Up to | ||||||||||||
| 44563W/cm² | Up to | ||||||||||||
| 3138W/cm² | unknown | ||||||||||||
| Wavelength | 980 ±10 nm | 980 ±10 nm | 980 ± 10 nm, or | ||||||||||
| 810 ± 10nm, or | |||||||||||||
| dual (810+980) | 970 ± 15nm | 980 ±10 nm, or | |||||||||||
| 810 ± 10nm, or | |||||||||||||
| dual (810+980) | 980 ± 10 nm | Aiming beam | diode | ||||||||||
| max 1mW | |||||||||||||
| 625 - 670 nm | diode | ||||||||||||
| max 1mW | |||||||||||||
| 625 - 670 nm | diode | ||||||||||||
| max 5mW | |||||||||||||
| 640 - 650nm | diode, | ||||||||||||
| max 1mW | |||||||||||||
| 635 - 650nm | diode | ||||||||||||
| max 5mW | |||||||||||||
| 640 - 660nm | diode | ||||||||||||
| 650nm | |||||||||||||
| The devices cleared under K100474 and K152032 operate in 3 different wavelengths: 980nm alone, 810nm | |||||||||||||
| alone and dual (810+980nm). Biolase is claiming equivalence to the 980 nm version only. | |||||||||||||
| Therefore, substantially equivalent. | Control panel | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | Touch screen | ||||||
| Operating | |||||||||||||
| modes | Continuous, | ||||||||||||
| pulsed | Continuous, | ||||||||||||
| pulsed | Continuous, | ||||||||||||
| pulsed | Continuous, | ||||||||||||
| chopped(pulsed), | |||||||||||||
| peak pulse | Pulsed | Continuous, | |||||||||||
| pulsed | Activation | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | Footswitch | ||||||
| Max Power | |||||||||||||
| (CW) | 10 W | 10 W | 10W | 7W | 2W | 10 W | Delivery | ||||||
| system | Fiber optic cable, | ||||||||||||
| handpiece and | |||||||||||||
| disposable tips | Fiber optic cable, | ||||||||||||
| handpiece and | |||||||||||||
| disposable tips | Quarts glass fiber | Fiber optic cable, | |||||||||||
| handpiece and | |||||||||||||
| disposable tips | Quartz glass fiber | ||||||||||||
| and tips, handpiece | |||||||||||||
| and disposable tips | Optical fibers, | ||||||||||||
| handpieces and | |||||||||||||
| disposable tips | |||||||||||||
| Although Epic 980 is capable of reaching 10W max power, the power settings used for all expanded indications do | |||||||||||||
| not exceed 1W, which is sufficient for effective performance and also falls under the maximum power of devices | |||||||||||||
| cleared under K103753 and K152032. Therefore, substantially equivalent. | Fiber Tips | Quartz single-use | |||||||||||
| tips varying in | |||||||||||||
| length and core | |||||||||||||
| diameter | |||||||||||||
| (200 - 400μm) | Quartz single-use | ||||||||||||
| tips varying in | |||||||||||||
| length and core | |||||||||||||
| diameter | |||||||||||||
| (200 - 400μm) | Fiber | ||||||||||||
| (400μm) | Single use tips | ||||||||||||
| varying in core | |||||||||||||
| diameter | |||||||||||||
| (200 - 320 μm) | Quarts tips (400μm) | Single use tips | |||||||||||
| Max Peak | |||||||||||||
| Power | 10 W | 10 W | 10W @980, or | ||||||||||
| 10W @810, or | |||||||||||||
| 20W @ dual | 14W | 10W @980, or | |||||||||||
| 10W @810, or | |||||||||||||
| 20W @ dual | unknown | Materials | Medical grade | ||||||||||
| plastics, stainless | |||||||||||||
| steel, aluminum, | |||||||||||||
| brass, and | |||||||||||||
| electronic parts | |||||||||||||
| and components | Medical grade | ||||||||||||
| plastics, stainless | |||||||||||||
| steel, aluminum, | |||||||||||||
| brass, and | |||||||||||||
| electronic parts | |||||||||||||
| and components | Medical grade | ||||||||||||
| plastics, stainless | |||||||||||||
| steel, and electronic | |||||||||||||
| parts and | |||||||||||||
| components | Medical grade | ||||||||||||
| plastics, stainless | |||||||||||||
| steel, and electronic | |||||||||||||
| parts and | |||||||||||||
| components | Medical grade | ||||||||||||
| plastics, stainless | |||||||||||||
| steel, and electronic | |||||||||||||
| parts and | |||||||||||||
| components | Medical grade | ||||||||||||
| plastics, stainless | |||||||||||||
| steel, and electronic | |||||||||||||
| parts and | |||||||||||||
| components | |||||||||||||
| Repetition rate | |||||||||||||
| (Frequency) | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | Up to 20 kHz | 50 Hz | unknown |
8
9
Intended use and Indications for Use
| Epic 980
(subject device) | Epic 980
K192430 | QuickLase 810,980 &
Dual+
K100474 | SiroLaser Advance
K103753 | Elumi 810 + 980
K152032 | Curative 980
K082445 |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dental soft tissue
indications:
incision, excision,
vaporization, ablation
and coagulation of oral
soft-tissues including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and the
following specific
indications: | Dental soft tissue
indications:
Incision, excision,
vaporization, ablation
and coagulation of oral
soft-tissues including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and the
following specific
indications: | Intended for
incision, excision,
vaporization,
hemostasis and
treatment of oral soft-
tissue.
Examples: | Indicated for intra and
extraoral surgery
including incision.
excision, hemostasis,
coagulation and
vaporization of soft-
tissues including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and is indicated
for: | Soft tissue laser
intended for the
incision, excision,
vaporization,
hemostasis and
treatment of oral soft-
tissues. the following
are the oropharyngeal
indications for use: | Indicated for
incision, excision,
vaporization, ablation
and coagulation of oral
soft-tissues (intraoral
and extraoral) including
marginal and inter-
dental gingival and
epithelial lining of free
gingiva and the
following specific
indications: |
| excisional and
incisional biopsies | excisional and
incisional biopsies | excisional and
incisional biopsies | biopsies | excisional and
incisional biopsies | excisional and
incisional biopsies |
| exposure of unerupted
teeth | exposure of unerupted
teeth | exposure of unerupted
teeth | exposure of unerupted/
partially erupted teeth | exposure of unerupted
teeth | exposure of unerupted/
partially erupted teeth |
| fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal | fibroma removal |
| frenectomy | frenectomy | frenectomy | frenectomy | frenectomy | frenectomy |
| frenotomy | frenotomy | frenotomy | frenotomy | frenotomy | frenotomy |
| gingival troughing for
crown impressions | gingival troughing for
crown impressions | gingival troughing for
crown impressions | gingival troughing | gingival troughing for
crown impressions | gingival troughing for
crown impressions |
| gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy | gingivectomy |
| gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty | gingivoplasty |
| gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and | gingival incision and |
| excision | excision | excision | excision | excision | excision |
| hemostasis and | hemostasis and | hemostasis and | hemostasis of donor | hemostasis and | hemostasis and |
| coagulation | coagulation | coagulation | site | coagulation | coagulation |
| implant recovery | implant recovery | implant recovery | implant recovery | implant recovery | implant recovery |
| incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of | incision and drainage of |
| abscess | abscess | abscess | abscess | abscess | abscess |
| leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia | leukoplakia |
| operculectomy | operculectomy | operculectomy | operculectomy | operculectomy | operculectomy |
| oral papillectomies | oral papillectomies | oral papillectomies | papillectomy | oral papillectomies | oral papillectomies |
| pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy | pulpotomy |
| pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an | pulpotomy as an |
| adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal | adjunct to root canal |
| therapy | therapy | therapy | therapy | therapy | therapy |
| reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival | reduction of gingival |
| hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy | hypertrophy |
| soft-tissue crown | soft-tissue crown | soft-tissue crown | crown lengthening | soft-tissue crown | soft-tissue crown |
| lengthening | lengthening | lengthening | | lengthening | lengthening |
| treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker | treatment of canker |
| sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and | sores, herpetic and |
| aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the | aphthous ulcers of the |
| oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa | oral mucosa |
| vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty | vestibuloplasty |
| tissue retraction for
impression | tissue retraction for
impression | tissue retraction for
impression | tissue retraction for
impression | tissue retraction for
impression | tissue retraction for
impression |
| laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue | laser soft-tissue |
| curettage | curettage | curettage | curettage | curettage | curettage |
| laser removal of | laser removal of | laser removal of | NA | laser removal of | NA |
| diseased, infected, | diseased, infected, | diseased, infected, | diseased, infected, | diseased, infected, | |
| inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | inflamed and necrosed | |
| soft-tissue within the | soft-tissue within the | soft-tissue within the | soft-tissue within the | soft-tissue within the | |
| periodontal pocket | periodontal pocket | periodontal pocket | | periodontal pocket | |
| sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement | sulcular debridement |
| (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, | (removal of diseased, |
| infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and | infected, inflamed and |
| necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in | necrosed soft-tissue in |
| the periodontal pocket | the periodontal pocket | the periodontal pocket | | the periodontal pocket | the periodontal pocket |
| to improve clinical | to improve clinical | to improve clinical | | to improve clinical | to improve clinical |
| indices including | indices including | indices including | | indices including | indices including |
| gingival index, gingival | gingival index, gingival | gingival index, gingival | | gingival index, gingival | gingival index, gingival |
| bleeding index, probe | bleeding index, probe | bleeding index, probe | | bleeding index, probe | bleeding index, probe |
| depth, attachment loss | depth, attachment loss | depth, attachment loss | | depth, attachment loss | depth, attachment loss |
| and tooth mobility) | and tooth mobility) | and tooth mobility) | | and tooth mobility) | and tooth mobility) |
| light activation for | light activation for | light activation for | NA | light activation for | light activation for |
| bleaching materials for | bleaching materials for | bleaching materials for | | bleaching materials for | bleaching materials for |
| teeth whitening | teeth whitening | teeth whitening | | teeth whitening | teeth whitening |
| laser-assisted | laser-assisted | laser-assisted | NA | laser-assisted | laser-assisted |
| whitening/bleaching of | whitening/bleaching of | whitening/bleaching of | | whitening/bleaching of | whitening/bleaching of |
| teeth | teeth | teeth | | teeth | teeth |
| topical heating for the
purpose of elevating
tissue temperature for a
temporary relief of
minor muscle and joint
pain and stiffness,
minor arthritis pain, or
muscle spasm, minor
sprains and strains, and
minor muscular back
pain; the temporary
increase in local blood | topical heating for the
purpose of elevating
tissue temperature for a
temporary relief of
minor muscle and joint
pain and stiffness,
minor arthritis pain, or
muscle spasm, minor
sprains and strains, and
minor muscular back
pain; the temporary
increase in local blood | NA | NA | NA | topical heating for the
purpose of elevating
tissue temperature for a
temporary relief of
minor muscle and joint
pain and stiffness,
minor arthritis pain, or
muscle spasm, minor
sprains and strains, and
minor muscular back
pain; the temporary
increase in local blood |
| circulation; the
temporary relaxation of
muscle. | circulation; the
temporary relaxation of
muscle. | | | circulation; the
temporary relaxation of
muscle. | circulation; the
temporary relaxation of
muscle. |
| Reduction of bacterial
level(decontamination)
and inflammation | NA | Reduction of bacterial
level (decontamination)
and inflammation | NA | Reduction of bacterial
level (decontamination)
and inflammation | Reduction of bacterial
level (decontamination)
and inflammation |
| Removal of highly
inflamed edematous
tissue affected by
bacteria penetration of
the pocket lining and
junctional epithelium | NA | Removal of highly
inflamed edematous
tissue affected by
bacteria penetration of
the pocket lining and
junctional epithelium | NA | Removal of highly
inflamed edematous
tissue affected by
bacteria penetration of
the pocket lining and
junctional epithelium | NA |
| Lesion (tumor) removal | NA | Lesion (tumor) removal | NA | Lesion (tumor) removal | NA |
| Laser assisted flap
surgery | NA | NA | Laser assisted flap
surgery | NA | Laser assisted flap
surgery |
| Removal of granulation
tissue | NA | NA | Removal of granulation
tissue | NA | Removal of granulation
tissue |
| Removal of
hyperplastic tissues | NA | NA | Removal of
hyperplastic tissues | NA | NA |
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VII. PERFORMANCE DATA
Clinical and Bench Testing
Since the expanded indications for use have been already cleared for equivalent devices, therefore any additional clinical and/or performance testing was not required.
Biocompatibility and Sterilization Testing
No new biocompatibility and sterilization testing were performed. All patient-contacting accessories remain the same as previously cleared under K192430.
Electrical Safety and Electromagnetic Compatibility (EMC)
All relevant electrical safety and EMC testing have been conducted in accordance with current recognized standards. The Epic 980 diode laser complies with the requirements.
IEC 60601-1-2:2014 Medical electrical equipment- Part 1-2- electromagnetic compatibility (EMC)
IEC 60601-1:2012
Medical electrical equipment - Part 1: general requirements for basic safety and essential performance
IEC 60601-2-22:2007+ A1:2012
Medical electrical equipment- Part 2-22: particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment
IEC 60825-1:2014
Safety of laser products- Part 1: equipment classification and requirements
IEC 80601-2-60:2012
Medical electrical equipment - Part 2-60: particular requirements for the basic safety and essential performance of dental equipment
Software Verification and Validation
Software contained in Epic 980 was developed, tested and documented in accordance with IEC 62304:2015 – Medical Device Software - Software Lifecycle and the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices". Verification and validation testing demonstrate performance according to specifications and functions intended.
VIII. CONCLUSION
Comparison of the Epic 980 subject device with the predicate devices demonstrate substantial equivalence in technological and performance characteristics and supports the safety and effectiveness of the Epic 980 for the stated indications for use.