(76 days)
Epic Pro, K163128
Not Found
No
The summary describes a laser system for soft tissue procedures and teeth whitening, focusing on the laser technology and its delivery system. There is no mention of AI or ML in the intended use, device description, or performance studies. The "Automatic Power Control" mentioned in the intended use is likely a feedback mechanism based on sensor readings, not an AI/ML algorithm.
Yes
The device is used for medical procedures such as incision, excision, vaporization, ablation, hemostasis, or coagulation of soft tissue, and treatment of various dental conditions, which are therapeutic interventions.
No
The device is described as a surgical device used for various procedures like incision, excision, vaporization, and coagulation of soft tissue, as well as teeth whitening. There is no mention of it being used for diagnosis, only treatment.
No
The device description explicitly states it is a "diode laser system" and describes hardware components like a solid-state diode, fiber, handpiece, and wireless footswitch. While it mentions software verification and validation, it is clearly a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Epic Pro 940 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser for various soft tissue procedures in dentistry and general surgery. These procedures involve direct interaction with the patient's body for treatment purposes.
- Device Description: The description details a surgical laser system that delivers energy to the treatment site via a fiber and handpiece. This is consistent with a surgical device, not a device used to examine specimens outside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, tissue samples, etc.) outside the body to provide information for diagnosis, monitoring, or screening. The procedures listed are all therapeutic or involve direct tissue manipulation.
Therefore, the Epic Pro 940 falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indication, incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival; examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The Epic Pro 940 with surgical laser operation, used in contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.
The Epic Pro 940 with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
Product codes
GEX
Device Description
Epic Pro 940 diode laser system is a surgical device designated for a wide variety of surgical and oral soft-tissue procedures and dental whitening. Epic Pro 940 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival)
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)
Biocompatibility Testing: The biocompatibility evaluation of the modified device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The results demonstrate biocompatibility of the device and its accessories.
Electrical Safety and Electromagnetic Compatibility (EMC): Electrical safety and electromagnetic compatibility testing of Epic Pro 940 was conducted according to the recognized standards. The device passed the required testing and is in full compliance with the standards: IEC 60601-1-2, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 80601-2-60, IEC 62366-1, IEC 60601-1-6.
Software Verification and Validation: Software contained in Epic Pro 940 was developed in accordance with IEC 62304. Software verification and validation testing was performed and documentation provided per the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Bench Testing: Ex-vivo animal tissue testing was performed to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro 940 performs as well as the predicate device, Epic Pro.
Clinical Testing: Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent.
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 Pro, K163128
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and 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.
November 29, 2017
Biolase, Inc Alicia Mszyca Manager, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K172771
Trade/Device Name: Epic Pro 940 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: September 11, 2017 Received: September 14, 2017
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. 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 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);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Jennifer R. Stevenson -S3 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) K172771
Device Name Epic Pro 940 Diode Laser System
Indications for Use (Describe)
The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indication, incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingival; examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectorny, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The Epic Pro 940 with surgical laser operation, used in contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.
The Epic Pro 940 with dental laser operation is intended for incision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal gingiva and epithelial lining of free gingiva); examples include: frenectomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
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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SECTION 5
510(k) Summary
Biolase, Inc. Epic Pro 940 – 510(k) Submission
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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: September 11, 2017
II. DEVICE
| Name of Device: | Epic Pro 940 Diode Laser System |
|---|---|
| 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 |
PREDICATE DEVICE III.
Epic Pro, K163128
DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.
Epic Pro 940 diode laser system is a surgical device designated for a wide variety of surgical and oral soft-tissue procedures and dental whitening. Epic Pro 940 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via a flexible fiber connected at one end to the laser source and the other end to the handpiece. Various types of single use disposable tips are designed and optimized for different applications. The device is activated by means of a wireless footswitch.
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V. INDICATIONS FOR USE
The Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket).
The Epic Pro 940 with surgical laser operation, used in contact or non-contact mode, is intended for use in general surgery for incision, excision, vaporization, ablation and coagulation of soft tissue.
The Epic Pro 940 with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extra-oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva); examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, removal of granulation tissue, hemostasis of donor site, treatment of aphthous ulcers, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted teeth/partially erupted teeth, leukoplakia, removal of hyperplastic tissues, laser assisted flap surgery, pulpotomy, pulpotomy as an adjunct to root canal therapy, sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket), light activation of bleaching materials for teeth whitening.
VI. SUMMARY OF SIMILARITIES AND DIFFERENCES
Epic Pro 940 is a modified version of Epic Pro (K163128). The change involved is limited to the replacement of the existing 980nm diode laser module, used in Epic Pro, with a 940nm diode in Epic Pro 940.
Epic Pro 940 operates the same as the predicate device and the modification does not impact the intended use and indications for use.
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Table 1 - Summary of technological characteristics between the subject and predicate device.
| Table 1 - Summary of technological characteristics between the subject and predicate device | ||
|---|---|---|
| Specification | Biolase, Inc | |
| Epic Pro 940 | ||
| (subject device) | Biolase, Inc | |
| Epic Pro/ K163128 | ||
| (predicate device) | ||
| Laser source | Diode | Diode |
| Wavelength | 940 nm | 980 nm |
| Max output power | 25 W | 25 W |
| Power range | 0.2-25 W | 0.2-25 W |
| Increments | 0.2-1 W | 0.2-1 W |
| Operating modes | Pulsed or CW | Pulsed or CW |
| Pulse width (duration) | 0.01-100 ms | 0.01-100 ms |
| Max pulse peak power | 150 W | 150 W |
| Timer duration | 50 ms to 99.9 s | 50 ms to 99.9 s |
| Spot size | 300-400 microns | 300-400 microns |
| Fluence per spot | 3 – 360 W/mm² | 3 – 360 W/mm² |
| Frequency (repetition rate) | Up to 20 kHz | Up to 20 kHz |
| Aiming beam | 650 nm, 5mW | 650 nm, 5mW |
| Cooling | Air cooled | Air cooled |
| Voltage | 120V/60Hz or 240V/50Hz | 120V/60Hz or 240V/50Hz |
| Control panel | Color touch screen | Color touch screen |
| Laser activation | Wireless footswitch | Wireless footswitch |
| Delivery system | Fiber optic cable, handpiece and disposable fiber tips | Fiber optic cable, handpiece and disposable fiber tips |
| Indications for use | Epic Pro 940 with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty | Epic Pro with surgical laser operation (Automatic Power Control) used in contact or non-contact mode, is indicated for dental soft tissue indications including: incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery/uncovery, gingivectomy, gingivoplasty |
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gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining. incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues , and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Epic Pro 940 with surgical laser operation used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue: and Epic Pro 940 with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site. removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue
gingival troughing, crown lengthening, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining. incisions and draining of abscesses, tissue retraction for impressions, papillectomy, vestibuloplasy, excision of lesions, exposure of unerupted/partially erupted teeth, leukoplakia, removal of hyperplastic tissues , and sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket). Epic Pro with surgical laser operation used in contact or noncontact technique is intended for use in general surgery for incision/excision, vaporization, ablation and coagulation of soft tissue: and Epic Pro with dental laser operation is intended for incision, excision, vaporization, ablation, hemostasis, or coagulation of intraoral and extraoral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). Examples include: frenectomy, frenotomy, biopsy, operculectomy, implant recovery, gingivectomy, gingivoplasty, gingival troughing, crown lengthening, hemostasis of donor site, removal of granulation tissue, laser assisted flap surgery, debridement of diseased epithelial lining, incisions and draining of abscesses, tissue
8
| retraction for impressions, | retraction for impressions, |
|---|---|
| papillectomy, vestibuloplasy, | papillectomy, vestibuloplasy, |
| excision of lesions, exposure of | excision of lesions, exposure of |
| unerupted/partially erupted teeth, | unerupted/partially erupted teeth, |
| leukoplakia, removal of | leukoplakia, removal of |
| hyperplastic tissues, treatment of | hyperplastic tissues, treatment of |
| aphthous ulcers, sulcular | aphthous ulcers, sulcular |
| debridement (removal of | debridement (removal of |
| diseased or inflamed soft tissue | diseased or inflamed soft tissue |
| in the periodontal pocket), | in the periodontal pocket), |
| pulpotomy, pulpotomy as an | pulpotomy, pulpotomy as an |
| adjunct to root canal therapy, | adjunct to root canal therapy, |
| and light activation of bleaching | and light activation of bleaching |
| materials for teeth whitening. | materials for teeth whitening. |
VII. PERFORMANCE DATA
The following performance data has been generated in support of substantial equivalence determination:
Biocompatibility Testing
The biocompatibility evaluation of the modified device was conducted in accordance with ISO 10993-1 Biological Evaluation of Medical Devices- Part 1: Evaluation and Testing within a Risk Management Process, as recognized by the FDA. The results demonstrate biocompatibility of the device and its accessories.
Electrical Safety and Electromagnetic Compatibility (EMC)
Electrical safety and electromagnetic compatibility testing of Epic Pro 940 was conducted according to the recognized standards. The device passed the required testing and is in full compliance with the standards:
- IEC 60601-1-2: Medical electrical equipment Part 1-2: General requirements for ● safety - collateral standard: electromagnetic compatibility (EMC)- requirements and test
- IEC 60601-1: Medical electrical equipment Part 1: General requirements for ● basic safety and essential performance
- IEC 60601-2-22: 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: Safety of Laser Products Part 1: Equipment classification and ● requirements
9
- IEC 80601-2-60: Medical electrical equipment Part 2-60: Particular requirements ● for the basic safety and essential performance of dental equipment
- IEC 62366-1: Medical devices Part 1: Application of Usability Engineering to ● medical devices
- . IEC 60601-1-6: Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance -collateral standard: usability
Software Verification and Validation
Software contained in Epic Pro 940 was developed in accordance with IEC 62304. Software verification and validation testing was performed and documentation provided per the FDA guidance document "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices".
Bench Testing
Ex-vivo animal tissue testing was performed to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro 940 performs as well as the predicate device, Epic Pro.
Clinical Testing
Clinical testing was not performed for the subject device since the indications for use are the same as for the predicate device and the performance characteristics are equivalent.
VIII. CONCLUSION
Epic Pro 940 has the same intended use, indications for use as well as fundamental scientific technology as its legally marketed predicate. Epic Pro (K163128). Performance data demonstrates that the modification incorporated to Epic Pro 940 does not raise any new safety or efficacy concerns. Therefore, it can be concluded that the Epic Pro 940 device is substantially equivalent to its predicate.