EPIC 10

K140120 · Biolase, Inc. · GEX · Oct 10, 2014 · General, Plastic Surgery

Device Facts

• Record ID: K140120
• Device Name: EPIC 10
• Applicant: Biolase, Inc.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use: General Surgery, Dermatology, Plastic Surgery and Podiatry - Debridement of wounds .

Device Story

Epic 10 is a diode laser surgical system; uses InGaAsP solid state laser diode to emit infrared energy (940nm); energy transmitted via flexible fiber optic cable to handpiece for soft tissue surgery; visible aiming beam identifies treatment site; system includes base console, delivery system, single-use tips, and wireless footswitch; operated by clinicians in surgical/clinical settings; provides precise tissue interaction for incision, excision, vaporization, ablation, and hemostasis; benefits include controlled tissue removal and coagulation; output controlled by clinician via footswitch.

Clinical Evidence

No clinical data. Substantial equivalence based on comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

Class IV diode laser; InGaAsP medium; 940nm wavelength; 10W max power; continuous and pulse modulation modes; pulse repetition rate up to 20 KHz; pulse duration 0.01-20 ms; aiming beam 625-670nm (Class 3B); materials include medical grade plastics, stainless steel, aluminum, brass; wireless footswitch; fiber optic delivery.

Indications for Use

Indicated for soft tissue incision, excision, vaporization, ablation, hemostasis, coagulation, and wound debridement in general surgery, dermatology, plastic surgery, and podiatry.

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

• QUANTA Diode Laser Family (K100558)
• Ceralas D980 Diode Laser (Models D15, D25) (K072779)
• Vectra Laser System and Accessories (K060114)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top of the seal in a circular fashion. The seal is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 10, 2014

Biolase Incorporated Ms. Colleen Boswell Vice President, Regulatory Affairs/Quality Assurance 4 Cromwell Irvine, California 92618

Re: K140120 Trade/Device Name: Epic 10 Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 15, 2014 Received: September 16, 2014

Dear Ms. Boswell:

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

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device-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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Binita S. Ashar -S 2014.10.10 13:24:59 -04'00' 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

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K140120

### Indications for Use

### 510(k) Number (if known):

Device Name: Epic 10

## Indications for Use:

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use:

### General Surgery, Dermatology, Plastic Surgery and Podiatry

- Debridement of wounds .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

# Concurrence of CDRH, Office of Device Evaluation (ODE)

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Biolase - Epic 10 - 510(k) Submission

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# 510(k) Summary

### Submitter:

Biolase, Inc. 4 Cromwell Irvine, California 92618 [phone] - Phone [phone] - Facsimile Colleen Boswell - Contact Person Date Summary Prepared: October 2014

- Trade Name Epic 10 ●
- Common Name - Diode Laser
- Classification Name - Laser surgical instrument for use in general and plastic surgery and in dermatology, per 21 CFR 878.4810
- . Product Code - GEX

# Devices for Which Substantial Equivalence is Claimed:

- QUANTA Diode Laser Family, Quanta System, S.p.A., K100558
- Ceralas D980 Diode Laser (Models D15, D25), Biolitec, Inc., K072779
- Vectra Laser System and Accessories, Xintec Corporation, dba, Convergent Laser Technologies, . · K060114

### Device Description

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 handpiece 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 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 delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

### Statement of Intended Use

The Epic 10 is intended for use as a laser surgical instrument requiring the incision, excision, vaporization, ablation, and hemostasis, or coagulation of soft tissue. It is indicated for the following expanded Indications for Use:

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### General Surgery, Dermatology, Plastic Surgery and Podiatry

- Debridement of wounds

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# Summary of Technological Characteristics

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| Descriptive<br>Information | Epic 10<br>(K140120) | QUANTA Diode Laser Family<br>(K100558) | Ceralas Diode 980nm Laser<br>System (Models D15, D25)<br>(K072779) | Vectra Laser System and<br>Accessories<br>(K060114) |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company | Biolase, Inc. | Quanta System S.p.A. | Biolitec, Inc. | Xintec Corporation, dba,<br>Convergent Laser Technologies |
| Indications for Use | The Epic 10 is intended for<br>use as a laser surgical<br>instrument requiring the<br>incision, excision,<br>vaporization, ablation and<br>hemostasis, or coagulation<br>of soft tissue. It is<br>indicated for the following<br>expanded Indications for<br>Use: | General Surgery, Dermatology,<br>Plastic Surgery and Podiatry<br>Excision, ablation, vaporization<br>and photocoagulation of skin<br>lesions, hemostasis, incision,<br>excision, vaporization, ablation<br>and debulking of soft tissue,<br>abdominal, rectal, skin, fat or<br>muscle tissue and<br>dermabrasion. Examples<br>include: | General Surgery, Dermatology,<br>Plastic Surgery and Podiatry<br>Excision, ablation, vaporization<br>and photocoagulation of skin<br>lesions, hemostasis, incision,<br>excision, vaporization, ablation<br>and debulking of soft tissue,<br>abdominal, rectal, skin, fat or<br>muscle tissue and<br>dermabrasion. Examples<br>include: | General Surgery, Dermatology,<br>Plastic Surgery and Podiatry<br>Excision, ablation, vaporization<br>and photocoagulation of skin<br>lesions, hemostasis, incision,<br>excision, vaporization, ablation<br>and debulking of soft tissue,<br>abdominal, rectal, skin, fat or<br>muscle tissue and<br>dermabrasion. Examples<br>include: |
| | General Surgery,<br>Dermatology, Plastic<br>Surgery and Podiatry<br>Debridement of<br>wounds | Matrixectomy Excision of neuromas Excision of periungual and<br>subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus<br>ulcers Hepatobiliary tumors Mastectomy | Matrixectomy Excision of neuromas Excision of periungual and<br>subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus<br>ulcers Hepatobiliary tumors Mastectomy | Matrixectomy Excision of neuromas Excision of periungual and<br>subungual warts Excision of plantar warts Excision of keloids Liver resection Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus<br>ulcers Hepatobiliary tumors Mastectomy |
| Descriptive<br>Information | Epic 10<br>(K140120) | QUANTA Diode Laser Family<br>(K100558) | Ceralas Diode 980nm Laser<br>System (Models D15, D25)<br>(K072779) | Vectra Laser System and<br>Accessories<br>(K060114) |
| | | • Dermabrasion | • Dermabrasion | • Dermabrasion |
| | | • Vaporization and hemostasis<br>of capillary hemangioma | • Vaporization and hemostasis<br>of capillary hemangioma | • Vaporization and hemostasis<br>of capillary hemangioma |
| | | • Excision, vaporization and<br>hemostasis of abdominal<br>tumors | • Excision, vaporization and<br>hemostasis of abdominal<br>tumors | • Excision, vaporization and<br>hemostasis of abdominal<br>tumors |
| | | • Excisions, vaporization and<br>hemostasis of rectal<br>pathology | • Excisions, vaporization and<br>hemostasis of rectal<br>pathology | • Excisions, vaporization and<br>hemostasis of rectal<br>pathology |
| | | • Pilonidal cystectomy | • Pilonidal cystectomy | • Pilonidal cystectomy |
| | | • Herniorapphy | • Herniorapphy | • Herniorapphy |
| | | • Adhesiolysis | • Adhesiolysis | • Adhesiolysis |
| | | • Parathyroidectomy | • Parathyroidectomy | • Parathyroidectomy |
| | | • Laparoscopic<br>cholecystectomy | • Laparoscopic<br>cholecystectomy | • Laparoscopic<br>cholecystectomy |
| | | • Thyroidectomy | • Thyroidectomy | • Thyroidectomy |
| | | • Resection of organs | • Resection of organs | • Resection of organs |
| | | • Debridement of wounds | • Debridement of wounds | • Debridement of wounds |
| | | • Photocoagulation of<br>teleangectasis of the legs and<br>face | • Photocoagulation of<br>teleangectasis of the legs and<br>face | • Photocoagulation of<br>teleangectasis of the legs<br>and face |
| | | • Photocoagulation of vascular<br>lesions of the face and<br>extremities | • Photocoagulation of vascular<br>lesions of the face and<br>extremities | • Photocoagulation of<br>vascular lesions of the face<br>and extremities |
| | | • Endovascular coagulation of<br>the greater saphenous vein of<br>the thigh in patients with<br>superficial vein reflux | | • Endovascular coagulation of<br>the greater saphenous vein<br>of the thigh in patients with<br>superficial vein reflux |
| | | • Treatment of reticular veins | | • Treatment of reticular veins |
| Descriptive Information | Epic 10<br>(K140120) | QUANTA Diode Laser Family<br>(K100558)<br>and branch varicosities | Ceralas Diode 980nm Laser System (Models D15, D25)<br>(K072779) | Vectra Laser System and Accessories<br>(K060114)<br>and branch varicosities |
| Laser Classification | IV (4) | IV (4) | IV (4) | IV (4) |
| Operating Voltage | 100 - $240V-1.5A$ | 100 - 240V | 100 - 220V | 100 - 220 VAC |
| Laser Medium | InGaAs | Diode Laser | GaAlAs | Diode Laser |
| Wavelength | $940 \pm 10nm$ | 980nm | 980nm | $980nm \pm 10\% (882-1078 nm)$ |
| Current Frequency | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz | 50 - 60 Hz |
| Max Output Power | 10 W | 30W | 15W (D15), 25W (D25) | 10/20/30W; 60W; 80W; 100W; 120W |
| Power Mode | Continuous, Pulse Modulation | Continuous, Pulse Modulation | Continuous, Pulse Modulation | Continuous, Pulse Modulation |
| Pulse Repetition Rate | Up to 20 KHz | 1 - 200 Hz | Not Listed by Manufacturer | Not Listed by Manufacturer |
| Pulse Duration | 0.01 ms - 20 ms | 3 - 2500 ms | 0.01 - 99.9 sec | Not Listed by Manufacturer |
| Aiming Beam | Laser Diode, max 1mW,<br>625 - 670nm, Class 3B | Laser Diode, max 3mW, 635,<br>Class 3R | Laser Diode, max 4mW, 635 | Laser Diode, Green, 532 |
| Materials | Medical grade plastics, steel,<br>stainless steel, aluminum, brass, and<br>electronic parts and<br>components | Medical grade plastics, steel,<br>stainless steel, aluminum, brass,<br>and electronic parts and<br>components | Medical grade plastics, steel,<br>stainless steel, aluminum, brass<br>and electronic parts and<br>components | Medical grade plastics, steel,<br>stainless steel, aluminum, brass,<br>and electronic parts and<br>components |

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### Non-Clinical Test Data

Non-clinical testing was not performed on this device since the purpose of this 510(k) is to only expand the Indications for Use from the previous 510(k) clearance under 510(k) No. K130465. The indication included in this 510(k) has already been cleared by the FDA for equivalent medical devices manufactured by Quanta System, S.p.A., Biolitec Inc. and Xintec Corporation, dba, Convergent Laser Technologies.

## Clinical Test Data

Clinical testing was not conducted on this device.

### Conclusion

Based upon the comparison of the Epic 10 with the predicate devices previously cleared by the FDA, the clinical performance of the Epic 10 for the Indication for Use described above is deemed to be substantially equivalent to the legally-marketed predicate devices, the QUANTA Diode Laser Family, the Ceralas Diode 980nm Diode Laser (Models D15, D25) and the Vectra Laser System and Accessories.

### Biolase - Epic 10 - 510(k) Submission

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