EPIC 10

K121286 · Biolase Technology, Inc. · GEX · Sep 28, 2012 · General, Plastic Surgery

Device Facts

• Record ID: K121286
• Device Name: EPIC 10
• Applicant: Biolase Technology, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Sep 28, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

EPIC™ 10 is a diode laser system using an InGaAsP solid-state laser diode (940nm) to emit infrared energy. Energy is transmitted via flexible fiber optic cable to a handpiece for delivery to target tissue; a visible aiming beam identifies treatment sites. System includes base console, detachable delivery system, single-use tips, and wireless footswitch. Operated by dental professionals in clinical settings. For soft tissue procedures, laser energy performs incision, excision, vaporization, ablation, and coagulation. For periodontal use, it performs curettage and sulcular debridement. For whitening, it activates bleaching materials. For pain therapy, it provides topical heating to elevate tissue temperature, increasing local blood circulation and relaxing muscles. Output is controlled by the clinician via footswitch; clinical decision-making relies on standard dental judgment and patient medical history.

Clinical Evidence

Clinical testing was conducted specifically for the therapeutic heating (pain therapy) indication. Human subject testing demonstrated that the device safely and effectively performs pain therapy as described in the indications for use. No non-clinical performance data was presented; safety and effectiveness for other indications were supported by literature, references, and publications.

Technological Characteristics

InGaAsP solid-state laser diode; 940 ± 10nm wavelength; 10W max power; continuous and pulse modulation up to 20kHz; pulse duration 0.01ms - 10s. Class 3B aiming beam (635 ± 10nm, 1mW). Materials: medical grade plastics, steel, stainless steel, aluminum, brass. Dimensions: 14.5cm x 11.2cm x 16.5cm. Power: 100-230 VAC, 50-60Hz. Wireless footswitch connectivity.

Indications for Use

Indicated for dental patients requiring soft tissue oral surgery (incision, excision, ablation, coagulation), periodontal pocket debridement/curettage, teeth whitening, and patients requiring topical heating for temporary relief of minor muscle/joint pain, stiffness, arthritis, muscle spasms, sprains, strains, and back pain. Contraindicated for patients with medical conditions or medications that contraindicate laser/light sources, including specific allergies, heart/lung disease, malignancies, bleeding disorders, sleep apnea, or immune deficiency.

Regulatory Classification

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.

Predicate Devices

• ezlase™ (K083069, K083595, K061898, K082938)
• iLase™ (K093852)

Submission Summary (Full Text)

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# 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: [phone] |
| | Fax: [phone] |
| Submitter: | Robert Y. Yang |
| | Global Regulatory Affairs Manager |
| | Tel: [phone] |
| | e-mail: [e-mail] |
| Contact: | Ehab Esmail |
| | VP, Regulatory, Quality and Clinical |
| | Tel: [phone] |
| | e-mail: [e-mail] |

## 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 plastic<br>surgery and in dermatology; and infrared lamp |
| Regulatory Class: | II |
| Product Code: | GEX, ILY |

- 3. PREDICATE DEVICES
- ezlase™ by Biolase Technology, Inc. K083069, K083595, K061898, and K082938
- iLase™ by Biolase Technology, Inc. K093852

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## 4. DEVICE DESCRIPTION

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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

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## 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.

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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.

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| ezlase™ 10W | Lase™ | EPIC™ 10 | SE |
|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|----|
| Biolase Technology, Inc. | Biolase Technology, Inc. | Biolase Technology, Inc. | |
| K083069<br>November 23, 2008 | K093852<br>March 12, 2010 | Pending | |
| N(4) | N(4) | N(4) | ✓ |
| Medical grade plastics,<br>steel, stainless steel,<br>aluminum, brass, and<br>electronic parts and<br>components | Medical grade plastics,<br>steel, stainless steel,<br>aluminum, brass, and<br>electronic parts and<br>components | Medical grade plastics,<br>steel, stainless steel,<br>aluminum, brass, and<br>electronic parts and<br>components | ✓ |
| 3.5in x 7.0in x 2.5in<br>(8.5cm x 18cm x 6cm) | 4.7in x 4.0in x 2.8in<br>(11.9cm x 10.2cm x<br>7.1cm) | 5.7in x 4.4in x 6.5in<br>(14.5cm x 11.2cm<br>x16.5cm) | ✓ |
| 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, Pulse<br>Modulation | Continuous, Pulse<br>Modulation | Continuous, Pulse<br>Modulation | ✓ |
| 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, max<br>3mW, 630-670nm,<br>class 3B | Laser Diode, max<br>3mW, 630-670nm,<br>class 3B | Laser Diode, max<br>1mW, 635 ± 10nm,<br>class 3B | ✓ |
| Approved Indication<br>as per K083069 | Approved indication<br>as per K093852 with<br>"Tissue retraction for<br>impression" | Same as those<br>Indications cleared for<br>KD61898, K082938,<br>K083595,K083069 and<br>K093852 | ✓ |

K121286 J. 5110

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| 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

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| 12 | 2 | 2 | 2 | 2 | 1 | 1 | 1 | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

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| • 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 |

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0.6/10 121786

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| periodontal pocket<br>• 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<br>• 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<br>• 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<br>• 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<br>• Light activation for bleaching materials for teeth whitening<br>• Laser-assisted whitening/bleaching of teeth | 3.Whitening<br>• Light activation for bleaching materials for teeth whitening<br>• Laser-assisted whitening/bleaching of teeth | | 4.Pain Therapy |
| | | | • Topical heating for the purpose of |

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121286 4. 91 10

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| elevating tissue<br>temperature for a<br>temporary relief<br>of minor muscle<br>and joint pain and<br>stiffness, minor<br>arthritis pain, or<br>muscle spasm,<br>minor sprains and<br>strains, and minor<br>muscular back<br>pain; the<br>temporary<br>increase in local<br>blood circulation;<br>the temporary<br>relaxation of<br>muscle | • Topical heating<br>for the purpose of<br>elevating tissue<br>temperature for a<br>temporary relief of<br>minor muscle and<br>joint pain and<br>stiffness, minor<br>arthritis pain, or<br>muscle spasm,<br>minor sprains and<br>strains, and minor<br>muscular back<br>pain; the<br>temporary increase<br>in local blood<br>circulation; the<br>temporary<br>relaxation of<br>muscle. |
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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

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## 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 [phone] or [phone] 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

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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