(151 days)
- 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
- 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 Periodontal Procedures
- Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
- 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.
The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC"" 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
Here's an analysis of the provided text, outlining the acceptance criteria and study details for the EPIC™ 10 device, based only on the information given:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical or performance-based "acceptance criteria" for the EPIC™ 10 device. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. This means the acceptance criterion for regulatory clearance is that the EPIC™ 10 is as safe, as effective, and performs as well as the previously cleared predicate devices for the same indications for use.
Therefore, the "reported device performance" is primarily a statement of its equivalency to the predicate devices and the successful completion of a clinical test for Pain Therapy, rather than specific quantitative metrics for each indication.
| Acceptance Criterion (Implicit) | Reported Device Performance and Evidence Provided |
|---|---|
| Substantial Equivalence to Predicate Devices: | The submission states: "Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC™ 10 system is as safe, as effective, and performs as well as the predicate devices."The key evidence for this is:Technological Characteristics Comparison: A detailed table (Appendix 1, partially provided) comparing the EPIC™ 10's design, material, chemical composition, energy source, size, weight, power, wavelength, maximum power, modulation, frequency, pulse duration, and aiming beam to predicate devices (ezlase™ 10W and iLase™), showing substantial similarity.Indications for Use Comparison: A table (Appendix 1, partially provided) demonstrating that all indications for use for the EPIC™ 10 are identical to, or a combination of, the indications cleared for the predicate devices (K061898, K082938, K083595, K083069, and K093852). No new indications are added.Non-clinical Performance Data: "Non-clinical performance data is not presented." Instead, an "Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices." |
| Safety and Effectiveness for Pain Relief Indication (Clinical): | "The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- For the Pain Therapy indication: "human subjects" were used. The specific number of subjects (sample size) is not provided in the text.
- For all other indications: No specific "test set" or sample size is mentioned, as substantial equivalence is claimed based on prior predicate device clearances and literature review, not new clinical testing for these indications.
- Data Provenance:
- For the Pain Therapy indication: "conducted with human subjects." The country of origin is not specified.
- It is a prospective study for the Pain Therapy indication, as it was conducted specifically for this device against those indications.
- For other indications, the data provenance relates to the predicate devices' clearances and literature, which is not detailed here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: This information is not provided for the "Pain Therapy" clinical test or for establishing ground truth for any other part of the submission.
- Qualifications of Experts: This information is not provided.
4. Adjudication Method (for the test set)
- The adjudication method for the Pain Therapy clinical test is not described in the provided text.
- For other aspects, the reliance on prior predicate clearances implies that the "adjudication" was through the regulatory review process for those original devices and subsequent literature review for this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- An MRMC comparative effectiveness study is not mentioned or described in the provided text.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- This device is a laser system, not an algorithm. Therefore, the concept of a "standalone (algorithm only without human-in-the-loop performance) study" is not applicable. The device is designed for human operation.
7. Type of Ground Truth Used
- For the Pain Therapy indication's clinical test: The ground truth appears to be based on direct clinical assessment of patient responses to "Pain Therapy" (e.g., pain relief, symptom change), as implied by "performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively." It is not explicitly stated as expert consensus, pathology, or specific outcomes data, but rather the observed clinical effect in human subjects.
- For other indications: The ground truth rests on the established safety and effectiveness of the predicate devices for their cleared indications, supported by literature review.
8. Sample Size for the Training Set
- This device is a hardware system, not an AI/ML algorithm that requires a "training set" in the conventional sense. Therefore, the concept of a "sample size for the training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
- As above, the concept of a "training set" and its ground truth establishment is not applicable to this device.
{0}------------------------------------------------
$\times 12.1286. \theta. 1/n$
.
Special 510(k) Summary for EPIC™ 10 by Biolase Technology, Inc. (As required by 21CFR 807.92)
1. GENERAL INFORMATION
| Date Prepared: | April 20, 2012 |
|---|---|
| Company: | Biolase Technology, Inc. |
| 4 Cromwell | |
| Irvine, CA 92618 | |
| Tel: (949) 361-1200 | |
| Fax: (949) 273-6687 | |
| Submitter: | Robert Y. Yang |
| Global Regulatory Affairs Manager | |
| Tel: (949) 226-8147 | |
| e-mail: ryang@biolase.net | |
| Contact: | Ehab Esmail |
| VP, Regulatory, Quality and Clinical | |
| Tel: (949) 226-8469 | |
| e-mail: eesmail@biolase.net |
2. NAMES / REGULATIONS
| Trade/Device Name: | EPIC™ 10 |
|---|---|
| Common Name: | Diode Laser |
| Regulation Number: | 21CFR 878.4810, and 21CFR 890.5500 |
| Classification name: | Laser surgical instrument for use in general and plasticsurgery and in dermatology; and infrared lamp |
| Regulatory Class: | II |
| Product Code: | GEX, ILY |
-
- PREDICATE DEVICES
{1}------------------------------------------------
4. DEVICE DESCRIPTION
31 12:2
。
2017年
2017年 - 2
The EPIC™ 10 system uses an Indium Gallium Arsenide Phosphorous (InGaAsP) solid state laser diode to emit infrared laser energy which is transmitted via a flexible fiber optic cable to a hand piece that emits the energy to the target site. A visible light is emitted at the same time to visually identify the treatment location. The EPIC™ 10 Laser System is comprised of a Base Console, a detachable delivery system, tips, and a wireless footswitch. Various types of the single use tips are included for different applications and the device is activated by means of a wireless footswitch. The EPIC"" 10 Laser is a surgical and therapeutic device designed for a wide variety of oral soft tissue procedures and dental whitening, as well as for use in providing temporary relief of minor pain.
5. INDICATIONS FOR USE
The indications are identical to that of the previously cleared predicate systems,
1. 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
- 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
{2}------------------------------------------------
$\mu 21286 \rho. 3/D$
2. Laser Periodontal Procedures
- Laser soft tissue curettage
- Laser removal of diseased, infected, inflamed and necrosed soft tissue . within the periodontal pocket
- Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
3. Whitening
•
.
- Light activation for bleaching materials for teeth whitening
- Laser-assisted whitening/bleaching of teeth
4. Pain Relief
- 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.
6. DEVICE TECHNOLOGICAL CHARACTERISTICS
The device EPIC" 10 system has the same fundamental technological characteristics (i.e., design, material, chemical composition, energy source) as the predicate devices. A summary of the technological characteristics of this device in comparison to those of the company's owned predicate devices is included in the body of the special 510(k) submission.
7. PERFORMANCE ASSESSMENT
Non-clinical performance data is not presented. An Evaluation Report including the references, literature and publications is included in the 510(k) submission for the demonstration of safety and effectiveness of this device and to support substantial equivalence to the company's owned legally marketed devices.
The clinical test for the therapeutic heating device indications (Pain Therapy) listed in Item 4 of the IFU have been conducted with human subjects and the performance data demonstrated that the device can perform the pain therapy as described in the indication for use safely and effectively.
{3}------------------------------------------------
4121286 8. 4/10
8. CONTRAINDICATIONS
The contraindications are identical to that of the previously cleared ezlase™ and iLase™ system by Biolase Technology, Inc.
All clinical procedures performed with EPIC"M 10 must be subjected to the same clinical judgment and care as with traditional techniques. Patient risk must always be considered and fully understood before clinical treatment. The clinician must completely understand the patient's medical history prior to treatment. Exercise caution for general medical conditions that might contraindicate a local procedure. Such conditions may include allergy to local or topical anesthetics, heart disease, lung disease, malignancies, bleeding disorders, sleep apnea, immune system deficiency, or any medical conditions or medications that may contraindicate use of certain light/laser type sources associated with this device. Medical clearance from the patient's physician is advisable when doubt exists regarding treatment.
9. SUBSTANTIAL EQUIVALENCE
The purpose of this Special 510(k) is to consolidate the current ezlase™ systems and the iLase" system (K083069, K083595, K061898, K082938, and K 093852). It is a combination of indications for use and EPIC" 10 system relies upon the company's owned legally marketed devices and no new indications for use are added. The design changes do not affect or potentially alter the fundamental scientific technology of the device. Based on the information presented in this Special 510(k) the combined system EPIC"™ 10 is substantially equivalent to the sum of the legally marketed devices: ezlase™ and iLase™ systems.
The predicate device comparison table of the technological characteristics of the new device in comparison to those of the predicate device and the comparison table of the indications for use for each predicate and the subject device are shown in Appendix 1.
10. CONCLUSION
No new indications are added in this Special 510(k) and the device modifications do not potentially alter the fundamental scientific technology of the device. Substantial Equivalence for the EPIC™ 10 system has also been determined through comparison to the company's previous cleared devices. This Special 510(k) submission demonstrates that the EPIC"M 10 system is as safe, as effective, and performs as well as the predicate devices.
{4}------------------------------------------------
| ezlase™ 10W | Lase™ | EPIC™ 10 | SE |
|---|---|---|---|
| Biolase Technology, Inc. | Biolase Technology, Inc. | Biolase Technology, Inc. | |
| K083069November 23, 2008 | K093852March 12, 2010 | Pending | |
| N(4) | N(4) | N(4) | ✓ |
| Medical grade plastics,steel, stainless steel,aluminum, brass, andelectronic parts andcomponents | Medical grade plastics,steel, stainless steel,aluminum, brass, andelectronic parts andcomponents | Medical grade plastics,steel, stainless steel,aluminum, brass, andelectronic parts andcomponents | ✓ |
| 3.5in x 7.0in x 2.5in(8.5cm x 18cm x 6cm) | 4.7in x 4.0in x 2.8in(11.9cm x 10.2cm x7.1cm) | 5.7in x 4.4in x 6.5in(14.5cm x 11.2cmx16.5cm) | ✓ |
| 2 lbs (1.0kg) | 1.89 lbs (0.85kg) | 2.5 lbs (1.1kg) | ✓ |
| 100 - 240 ~ at 2A | 90 - 230 VAC | 100 - 230 ~ at 2A | ✓ |
| 50 - 60 HZ | 50 - 60 HZ | 50 - 60 HZ | ✓ |
| InGaAsP | InGaAsP | InGaAsP | ✓ |
| 940 ± 15nm | 940 ± 15nm | 940 ± 10nm | ✓ |
| 10 watts | 3.0 watts | 10 watts | ✓ |
| Continuous, PulseModulation | Continuous, PulseModulation | Continuous, PulseModulation | ✓ |
| Up to 10KHz | Up to 10KHz | Upto 20KHz | ✓ |
| 0.06 ms - 10 sec | 0.1 ms/ 1 ms | 0.01ms - 10 sec | ✓ |
| 0.06 ms - 10 sec | 0.2 ms/ 1 ms | 0.01ms - 10 sec | ✓ |
| Laser Diode, max3mW, 630-670nm,class 3B | Laser Diode, max3mW, 630-670nm,class 3B | Laser Diode, max1mW, 635 ± 10nm,class 3B | ✓ |
| Approved Indicationas per K083069 | Approved indicationas per K093852 with"Tissue retraction forimpression" | Same as thoseIndications cleared forKD61898, K082938,K083595,K083069 andK093852 | ✓ |
K121286 J. 5110
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:
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:
and the country of the country
·
: :
Company of Children
{5}------------------------------------------------
| Predicate | ezlase™ | ezlase™ | zlase™ | zlase™ 10W | iLase™ | EPIC™ 10 |
|---|---|---|---|---|---|---|
| 510(k) No | <061898 | K082938 | <083595 | 083065 | 093852 | <121286 |
| ndications | Dental So | .Dental Soft | Dental Sof | Dental Sof | ||
| for Use | sue Indicatio | ssue Indicatior | ssue Indication | ssue Indication | ||
| ncision, excision | ncision, excision | cision, excision | cision, excision | |||
| aporizatio | aporization | aporization | aporization | |||
| blation and | blation and | blation and | blation and | |||
| oagulation of ora | oagulation of ora | pagulation of ora | pagulation of or | |||
| oft tissues | oft tissues | oft tissues | oft tissues | |||
| ncluding margir | cluding margin | icluding margin: | cluding margi | |||
| nd inter-dent | nd inter-dent | nd inter-dent | nd inter-dent | |||
| ingival an | ingival and | ngival and | ngival an | |||
| oithelial lining c | oithelial lining of | oithelial lining c | ithelial lining | |||
| ree gingiva an he following | ree gingiva anu | ee gingiva an | ree gingiva an he following | |||
| he following | ne following | |||||
| specific | pecific | pecific | specific | |||
| ndications | ndications | ndications | ndications | |||
| xcisional an | xcisional an | xcisional an | ئxcisional an | |||
| cisional biopsie | cisional biopsie | cisional biopsie | cisional biopsie | |||
| Exposure | Exposure o | Exposure o | Exposure o | |||
| nerupted teet | nerupted teet | nerupted teet | nerupted teet | |||
| ibroma remov | broma remova | Fibroma remova | Fibroma remov | |||
| Frenector | · Frenectom | Frenectom | Frenectom |
长121266 p: 6/10
{6}------------------------------------------------
| 12 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
.
| • Frenotomy | • Frenotomy | • Frenotomy | • Frenotomy |
|---|---|---|---|
| • Gingival troughing for crown impressions | • Gingival troughing for crown impressions | • Gingival troughing for crown impressions | • Gingival troughing for crown impressions |
| • Gingivectomy | • Gingivectomy | • Gingivectomy | • Gingivectomy |
| • Gingivoplasty | • Gingivoplasty | • Gingivoplasty | • Gingivoplasty |
| • Gingival incision and excision | • Gingival incision and excision | • Gingival incision and excision | • Gingival incision and excision |
| • Hemostasis and coagulation | • Hemostasis and coagulation | • Hemostasis and coagulation | • Hemostasis and coagulation |
| • Implant recovery | • Implant recovery | • Implant recovery | • Implant recovery |
| • Incision and drainage of abscess | • Incision and drainage of abscess | • Incision and drainage of abscess | • Incision and drainage of abscess |
| • Leukoplakia | • Leukoplakia | • Leukoplakia | • Leukoplakia |
| • Operculectomy | • Operculectomy | • Operculectomy | • Operculectomy |
| • Oral papillectomies | • Oral papillectomies | • Oral papillectomies | • Oral papillectomies |
| • Pulpotomy | • Pulpotomy | • Pulpotomy | • Pulpotomy |
| •Pulpotomy as an adjunct to root | •Pulpotomy as an adjunct to root | •Pulpotomy as an adjunct to root | •Pulpotomy as an adjunct to root |
:
{7}------------------------------------------------
Soft tissue croy phthous ulcers Laser soft tiss Tissue retract · Laser remova
Hiseased, infect ne oral mucos Vestibulo plas ecrosed soft
issue within th Treatment o Reduction c or impressio anker sores nflamed and erpetic and ypertroph Periodonta
Procedures engthenin urettage ingival 2.Laser seased, infecte ïssue retracti _aser soft tissu own lengthen hthous ulcers aser removal ecrosed soft
issue within th ne oral mucos estibulo plas Treatment o r impressio Reduction canker sores
nerpetic and nflamed an Soft tissu 2.Laser
Periodonta ypertropl Procedure urettage ingiva
beriodonta
anal thera
anal therap
Laser removal of
seased, infected Soft tissue crow Laser soft tissu phthous ulcers he oral mucosa necrosed soft
tissue within th /estibuloplas Treatment o Reduction o tanker sores herpetic and nflamed an anal therap Periodonta
Procedures ypertroph engthenin curettage gingiva 2.Laser Laser removal c
iseased, infected oft tissue crow ohthous ulcers Laser soft tissu ne oral mucost festibuloplas issue within th Treatment o Reduction o ecrosed sof canker sores
ierpetic and flamed and anal therap ypertroph Periodonta ngthenin Procedure urettage 2.Laser ingival
0.6/10 121786
{8}------------------------------------------------
| periodontal pocket• Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) | periodontal pocket• Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) | periodontal pocket• Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) | periodontal pocket• Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.) |
|---|---|---|---|
| 3.Whitening• Light activation for bleaching materials for teeth whitening• Laser-assisted whitening/bleaching of teeth | 3.Whitening• Light activation for bleaching materials for teeth whitening• Laser-assisted whitening/bleaching of teeth | 4.Pain Therapy | |
| • Topical heating for the purpose of |
:
.
121286 4. 91 10
:
{9}------------------------------------------------
| elevating tissuetemperature for atemporary reliefof minor muscleand joint pain andstiffness, minorarthritis pain, ormuscle spasm,minor sprains andstrains, and minormuscular backpain; thetemporaryincrease in localblood circulation;the temporaryrelaxation ofmuscle | • Topical heatingfor the purpose ofelevating tissuetemperature for atemporary relief ofminor muscle andjoint pain andstiffness, minorarthritis pain, ormuscle spasm,minor sprains andstrains, and minormuscular backpain; thetemporary increasein local bloodcirculation; thetemporaryrelaxation ofmuscle. |
|---|---|
| -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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KILI286 1.10/10
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{10}------------------------------------------------
Image /page/10/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Biolase Technologoy, Incorporated % Mr. Robert Y. Yang Global Regulatory Affairs Manager 4 Cromwell Irvine, California 92618
Re: K121286
Trade/Device Name: EPIC™ 10
Regulation Number: 21 CFR 878.4810, 890.5500 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology, Infrared lamp
Regulatory Class: II Product Code: GEX, ILY Dated: September 17, 2012 Received: September 20, 2012
Dear Mr. Yang:
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
SEP 28 2012
{11}------------------------------------------------
Page 2 - Mr. Robert Y. Yang
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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Millman
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K121286 p. 1/2
..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..:..
Indications for Use
510(k) Number (if known): K121286
EPIC™ 10 Device (Trade) Name:
Indications for Use:
1. 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
- 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
2. Laser Periodontal Procedures
- Laser soft tissue curettage
- Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket
- Sulcular debridement (removal of diseased, infected, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility.)
3. Whitening
- Light activation for bleaching materials for teeth whitenittgivision Sign-Off)
- Laser-assisted whitening/bleaching of teeth
Division of Surgical, Orthopedic, and Restorative Devices
Mill RP Dade
Page 1 of 2
510(k) Number K121286
{13}------------------------------------------------
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. .
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Biolase Technology, Inc. Special 510(k) EPIC™ 10
4. 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.
X121286
Prescription Use X : (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil R. Ogden for mxm
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K121286
§ 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.