(64 days)
Not Found
No
The summary does not mention AI, ML, or any related technologies. The device description focuses on the laser technology and its delivery system.
Yes
The device is indicated for various surgical procedures involving soft tissue, such as incision, excision, vaporization, and coagulation, for dental and general surgical applications. These are all therapeutic actions.
No
The device description and intended use clearly state that the Epic Pro is a "surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening," focusing on procedures like incision, excision, vaporization, and coagulation, rather than diagnosing conditions.
No
The device description clearly states it is a "diode laser system" that utilizes a "solid state diode" and delivers energy via a "flexible fiber connected at one end to the laser source and at the other end to the handpiece." This indicates the device is a hardware system with a software component, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a surgical laser for performing procedures on soft tissue, both intraoral and extra-oral. This involves direct interaction with the patient's body for treatment purposes.
- Device Description: The description reinforces this by calling it a "surgical device" that delivers laser energy to a treatment site.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The device is used for direct surgical intervention.
Therefore, the Epic Pro diode laser system, as described, falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications 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, 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 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 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 (comma separated list FDA assigned to the subject device)
GEX
Device Description
Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening.
Epic Pro 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 at 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 gingiva)
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, specifically the patient-contacting elements of the delivery system, 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 battery of testing included cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. 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 was conducted according to the following recognized 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. The device passed all the required testing and is in compliance with the above-mentioned standards.
Software Verification and Validation: Software verification and validation testing was performed and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. The results demonstrate that Epic Pro performs according to specifications and functions intended.
Bench Testing: In-vitro testing was conducted on soft tissue to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro performs as well as the predicate device, stLase.
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.
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
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 11, 2017
Biolase. Inc Alicia Mszyca Manager, Regulatory Affairs 4 Cromwell Irvine, California 92618
Re: K163128
Trade/Device Name: Epic Pro 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 12, 2016 Received: December 14, 2016
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 (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Jennifer R. Stevenson -A
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) K163128
Device Name Epic Pro
Indications for Use (Describe)
The Epic Pro with surgical laser operation (Automatic Power Control) used in contact mode, is indicated for dental soft tissue indications 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, 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 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 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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3
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: November 4, 2016
II. DEVICE
| Name of Device: | Epic Pro 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 |
III. PREDICATE DEVICE
stLase, K111689
DESCRIPTION OF THE DEVICE SUBJECT TO PREMERKET NOTIFICATION IV.
Epic Pro diode laser system is a surgical device designed for a wide variety of surgical and oral soft tissue procedures and dental whitening.
Epic Pro 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 at 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.
4
V. INDICATIONS FOR USE
The 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 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 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 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 is a modified version of its predecessor, stLase (K111689) to include a new delivery system, wireless footswitch, and some software changes which are aimed to improve functionality and user experience. The intended use, indications for use and the fundamental scientific technology of the subject device, Epic Pro, and the predicate device, stLase, are the same.
5
Similarities:
- . The same technical design and operation;
- The same laser source, a semiconductor diode with the wavelength of 980 nm; ●
- The same max output power of 25W;
- The same aiming beam;
- Both devices are available in continuous wave (CW) and pulsed mode and may be ● used in contact and non-contact mode;
- Output power in CW mode can be controlled through the thermal feedback signal ● from end of the fiber (tip):
- Both devices are software-operated and the parameters are controlled by a touch screen control panel;
The key differences between the subject and the predicate device include:
- The predicate device employs a fiber delivery system in the form of strippable ● fiber consisting of a fiber optic connector, cable, handpiece and disposable adapters to hold fiber in the distal part. The modified device utilizes a detachable fiber cable that is used in conjunction with a multi-tip handpiece and disposable fiber tips;
- The predicate device is activated by means of a wired footswitch, whereas the subject device uses a wireless footswitch;
- Modification of pulse mode, allowing the laser to operate at higher peak powers (up ● to 150 W) using very short pulses (down to 10 microseconds) with average power below 25 W;
- . Output power in pulse mode can also be controlled through the thermal feedback signal from end of the fiber (tip);
| Specification | Biolase, Inc
Epic Pro
(subject device) | Biolase, Inc
(prior Dental Photonics, Inc.)
stLase/ K111689
(predicate device) |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Laser source | Diode | Diode |
| Wavelength | 980 nm | 980 nm |
| Max output power | 25 W | 25 W |
| Power range | 0.2-25 W | 0.5-25 W |
| Increments | 0.2-1 W | 0.1-0.5 W |
| Operating modes | Pulsed or CW | Pulsed or CW |
| Pulse width (duration) | 0.01-100 ms | 0.025 - 3 ms |
| Max pulse peak
power | 150 W | 25 W |
| | | |
| Timer duration | 50 ms to 99.9 s | 50 ms to 99.9 s |
| Spot size | 300 - 400 microns | 200 - 400 microns |
| Fluence per spot | 3 - 360 $W/mm^2$ | 3 - 800 $W/mm^2$ |
| 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 | Wired footswitch |
| Delivery system | Fiber optic cable, handpiece and
disposable fiber tips | Clevable fiber, handpiece holder
and disposable tip holder/guide
to hold the fiber |
| Indications for use | 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,
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 | stLase 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,
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 non-
contact 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
retraction for impressions,
papillectomy, vestibuloplasy,
excision of lesions, exposure of
unerupted/partially erupted teeth,
leukoplakia, removal of
hyperplastic tissues, treatment of
aphthous ulcers, sulcular
debridement (removal of
diseased or inflamed soft tissue
in the periodontal pocket),
pulpotomy, pulpotomy as an
adjunct to root canal therapy,
and light activation of bleaching | sulcular debridement (removal
of diseased or inflamed soft
tissue in the periodontal pocket).-
stLase with surgical laser
operation used in contact or non-
contact technique is intended for
use in general surgery for
incision/excision, vaporization,
ablation and coagulation of soft
tissue; and
stLase 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
retraction for impressions,
papillectomy, vestibuloplasy,
excision of lesions, exposure of
unerupted/partially erupted teeth
leukoplakia, removal of
hyperplastic tissues, treatment of
aphthous ulcers, sulcular
debridement (removal of
diseased or inflamed soft tissue
in the periodontal pocket),
pulpotomy, pulpotomy as an
adjunct to root canal therapy,
and light activation of bleaching | |
| | materials for teeth whitening. | materials for teeth whitening. |
Table 1 - Summary of technological characteristics between the subject and predicate device.
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7
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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, specifically the patientcontacting elements of the delivery system, 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 battery of testing included cytotoxicity, sensitization, intracutaneous reactivity and systemic toxicity. 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 was conducted according to the following recognized 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
- . 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
The device passed all the required testing and is in compliance with the abovementioned standards.
9
Software Verification and Validation
Software verification and validation testing was performed and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices. The results demonstrate that Epic Pro performs according to specifications and functions intended.
Bench Testing
In-vitro testing was conducted on soft tissue to evaluate performance between the subject device and its predicate. The results demonstrate that Epic Pro performs as well as the predicate device, stLase.
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 has the same intended use / indications for use as well as fundamental scientific technology as its legally marketed predicate, stLase (K111689). Performance data demonstrate that the modifications incorporated to Epic Pro do not raise any new safety or efficacy concerns. The technical design and operation are exactly the same. Therefore, Epic Pro is found to be substantially equivalent to the predicate device.