The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use: Ear, Nose and Throat and Oral Surgery, Arthroscopy, Gastroenterology, Orthopedics, General Surgery, Dermatology & Plastic Surgery, and Podiatry, GI/GU, Gynecology, Neurosurgery, Ophthalmology, Pulmonary Surgery, Cardiac Surgery, Thoracic Surgery, Urology, Dermatology/Aesthetics, Vascular Surgery.

Device Description

The EPIC 10S system uses an Indium 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 10S 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 10S delivery system consists of the following: Fiber Optic Assembly, Surgical Handpiece, and Single-use tips.

AI/ML Overview

The provided document is a 510(k) summary for the Biolase Epic 10S laser device. It explicitly states that no non-clinical or clinical test data was performed on this device for the purpose of this 510(k) submission.

Instead, the submission claims substantial equivalence to a legally marketed predicate device, the Diolase 10S (K121327), based on a comparison of technological characteristics and expanded Indications for Use. Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies is not present in this document.

The document indicates that the Epic 10S is substantially equivalent to the Diolase 10S for the stated indications.

Here's a breakdown of why the requested information cannot be provided based on the input:

A table of acceptance criteria and the reported device performance, Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective), Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience), Adjudication method (e.g. 2+1, 3+1, none) for the test set, If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance, If a standalone (i.e. algorithm only without human-in-the-loop performance) was done, The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The document states: "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 original 510(k) clearance under 510(k) No.: K121286. All indications included in this 510(k) have already been cleared by the FDA for an equivalent medical device manufactured by Biolase Technology, Inc." (Page 8).
- It also states: "Clinical testing was not conducted on this device." (Page 8).
- Therefore, there is no performance data, test set, ground truth, or details on reader studies for this submission. The device is being cleared based on its similarity to a previously cleared device.
The sample size for the training set, How the ground truth for the training set was established:
- Since no new clinical or non-clinical studies were conducted for this submission (as stated above), there is no training set mentioned or described within this document. The submission relies on the prior clearance of a predicate device.

In summary, the provided submission (K130465) relies on a claim of substantial equivalence to a predicate device (Diolase 10S, K121327) and did not involve new testing, clinical or non-clinical, to establish acceptance criteria or device performance.

Summary

{0}------------------------------------------------

K130465

Image /page/0/Picture/1 description: The image shows the word "BIOLASE" in a bold, outlined font. The letters are large and take up most of the frame. There is a vertical line to the right of the word.

nology. Inc.

510(k) Summary

APR: 1 1 2013

Submitter:

Biolase Technology, Inc. 4 Cromwell Irvine, California 92618 (949) 226-8470 - Phone (949) 273-6688 - Facsimile Colleen Boswell - Contact Person

Date Summary Prepared:

February 2013

. Trade Name - Epic 10S
. 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

Device for Which Substantial Equivalence is Claimed:

. Diolase 10S, Biolase Technology, Inc., K121327

Device Description

Statement of Intended Use

The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use:

Ear, Nose and Throat and Oral Surgery:

Hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity, such as:

{1}------------------------------------------------

Removal of benign lesions from ear, nose and throat
Excision and vaporization of vocal cord nodules and polyps
Incision and excision of carcinoma in-situ .
Ablation and vaporization of hyperkeratosis
. Laryngeal papillectomy
. Excision and vaporization of herpes simplex I and II
. Neck dissection

Arthroscopy:

Hemostasis, incision, excision, vaporization, and ablation of joint tissues during arthroscopic surgery, such as:

. Menisectomy
. Syovectomy
. Chondromalacia

Gastroenterology:

Hemostasis, incision, excision, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy, such as:

. Hemostasis of upper and lower G! bleeding
Excision and vaporization of colorectal carcinoma .
� Excision of polyps
. Hemostasis of colonoscopy
. Hemostasis of esophageal varices

Orthopedics:

. Dissect and coagulate

General Surgery, Dermatology & Plastic Surgery, and Podiatry:

Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation, and debulking of soft tissue, abdominal, rectal, skin, fat or muscle tissue, and dermabrasion, such as:

. Matrixectomy
. Excision of neuromas
. Excision of periungual and subungual warts
. Excision of plantar warts
. Excision of Keloids
. Excision of cutaneous lesions
. Hemorrhoidectomy
. Appendectomy
Debridement of decubitus ulcer
. Hepatobiliary
. Mastectomy
. Dermabrasion
Vaporization & hemostasis of capillary hemangioma
Excision, vaporization & hemostasis of abdominal tumors
Excision, vaporization & hemostasis of rectal pathology

{2}------------------------------------------------

Pilonidal cystectomy .
Herniorraphy �
. Adhesiolysis
. Parathyroidectomy
. Laparoscopic cholecystecomy
Thyroidectomy
� Resection of organs

GI/GU:

Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as:

Hemorrhoidectomy .
. Excision, vaporization, and hemostasis of rectal pathology
. Excision, vaporization, and hemostasis of abdominal tumors

Gynecology:

Ablation, excision, hemostasis, and vaporization of tissue, such as:

. Excision or vaporization of condylomata acuminata
. Vaporization of CIN (cervical intraepithelial neoplasia)
. Cervical conization
Menorrhagia .
� Ovarian cystectomy

Neurosurgery:

Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as:

Hemostasis in conjunction with meningiomas .
. Percutaneous Disc Decompression (PLDD)

Ophthalmology:

♥ Dacryocystorhinostomy transcanalicular
. Open DCR
. Tumor Excision
. Blepharoplasty

Pulmonary Surgery:

Hemostasis, vaporization, and excision of tissue, such as:

. Tracheobronchial malignancy or stricture
. Benign and malignant pulmonary obstruction

Cardiac Surgery:

. Coagulation and hemostasis of cardiac tissue

Thoracic Surgery:

. Thoracotomy
Pulmonary resection
. Hemostasis
Pericardiectomy
. Adhesiolysis
. Coagulation of blebs and bullae

{3}------------------------------------------------

Urology:

Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as:

. Vaporization of urethral tumors
� Release of urethral stricture
Removal of bladder neck obstruction .
� Excision and vaporization of condyloma
. Lesions of external genitalia
. Circumcision
Vaporization of the prostate to treat benign prostate hyperplasia (BPH) .

Dermatology/Aesthetics:

. Photocoagulation of vascular & dermatological lesions of the face and extremities
Photocoagulation of telangiectasia, venulectasia of the legs and face
. Treatment of reticular veins and branch varicosities
. Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
. Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi.
. Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semimalignant tumors as basaliomas, Bowe and Kaposi sarcoma, warty leucoplasty and ulcers debridement.
. Seborrheic keratosis
Mixoid cyst
. Papillary varix
. Acne treatment

Vascular Surgery:

. Photocoagulation of vascular & dermatological lesions of the face and extremities
. Photocoagulation of telangiectasia, veinulectasia of the legs and face
. Treatment of reticular veins and branch varicosities

Summary of Technological Characteristics

DescriptiveInformation	Epic 105	Diolase 10S (K121327)
Company	Biolase Technology, Inc.	Biolase Technology, Inc.
DescriptiveInformation	Epic 105	Diolase 10S (K121327)
	The Epic 10S is intended for use as a lasersurgical instrument in general and plasticsurgery and in dermatology. It is indicated forthe following expanded Indications for Use:	The Diolase 10S is intended for use as a lasersurgical instrument in general and plasticsurgery and in dermatology. It is indicated forthe following expanded Indications for Use:
	Ear, Nose and Throat and Oral Surgery:Hemostasis, incision, excision, ablation, andvaporization of tissues from the ear, nose,throat and adjacent areas, including soft tissuein the oral cavity, such as:	Ear, Nose and Throat and Oral Surgery:Hemostasis, incision, excision, ablation, andvaporization of tissues from the ear, nose,throat and adjacent areas, including soft tissuein the oral cavity, such as:
	Removal of benign lesions from ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in-situ Ablation and vaporization of hyperkeratosis Laryngeal papillectomy Excision and vaporization of herpes simplex I and II Neck dissection	Removal of benign lesions from ear, nose and throat Excision and vaporization of vocal cord nodules and polyps Incision and excision of carcinoma in-situ Ablation and vaporization of hyperkeratosis Laryngeal papillectomy Excision and vaporization of herpes simplex I and II Neck dissection
Indications for Use	Arthroscopy:Hemostasis, incision, excision, vaporization,and ablation of joint tissues duringarthroscopic surgery, such as:	Arthroscopy:Hemostasis, incision, excision, vaporization,and ablation of joint tissues duringarthroscopic surgery, such as:
	Menisectomy Syovectomy Chondromalacia	Menisectomy Syovectomy Chondromalacia
	Gastroenterology:Hemostasis, incision, excision, andvaporization of tissue in the upper and lowergastrointestinal tracts via endoscopy, such as:	Gastroenterology:Hemostasis, incision, excision, andvaporization of tissue in the upper and lowergastrointestinal tracts via endoscopy, such as:
	Hemostasis of upper and lower Gl bleeding Excision and vaporization of colorectal carcinoma Excision of polyps Hemostasis of colonoscopy Hemostasis of esophageal varices	Hemostasis of upper and lower Gl bleeding Excision and vaporization of colorectal carcinoma Excision of polyps Hemostasis of colonoscopy Hemostasis of esophageal varices
	Orthopedics:Dissect and coagulateSurgery, and Podiatry:Excision, ablation, vaporization, andphotocoagulation of skin lesions, hemostasis,	Orthopedics:Dissect and coagulate General Surgery, Dermatology & PlasticSurgery, and Podiatry:Excision, ablation, vaporization, andphotocoagulation of skin lesions, hemostasis,
DescriptiveInformation	Epic 10S	Diolase 10S (K121327)
	incision, excision, vaporization, ablation, anddebulking of soft tissue, abdominal, rectal,skin, fat or muscle tissue, and dermabrasion,such as:	incision, excision, vaporization, ablation, anddebulking of soft tissue, abdominal, rectal,skin, fat or muscle tissue, and dermabrasion,such as:
	Matrixectomy Excision of neuromas Excision of periungual and subungualwarts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillaryhemangioma Excision, vaporization & hemostasis ofabdominal tumors Excision, vaporization & hemostasis ofrectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs	Matrixectomy Excision of neuromas Excision of periungual and subungualwarts Excision of plantar warts Excision of Keloids Excision of cutaneous lesions Hemorrhoidectomy Appendectomy Debridement of decubitus ulcer Hepatobiliary Mastectomy Dermabrasion Vaporization & hemostasis of capillaryhemangioma Excision, vaporization & hemostasis ofabdominal tumors Excision, vaporization & hemostasis ofrectal pathology Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs
	GI/GU:Excision, vaporization, and hemostasis ofabdominal and rectal tissues, such as:Hemorrhoidectomy Excision, vaporization, and hemostasisof rectal pathology Excision, vaporization, and hemostasisof abdominal tumors	GI/GU:Excision, vaporization, and hemostasis ofabdominal and rectal tissues, such as:Hemorrhoidectomy Excision, vaporization, and hemostasisof rectal pathology Excision, vaporization, and hemostasisof abdominal tumors
	Gynecology:Ablation, excision, hemostasis, andvaporization of tissue, such as:Excision or vaporization ofcondylomata acuminata Vaporization of CIN (cervicalintraepithelial neoplasia)	Gynecology:Ablation, excision, hemostasis, andvaporization of tissue, such as:Excision or vaporization ofcondylomata acuminata Vaporization of CIN (cervicalintraepithelial neoplasia)
DescriptiveInformation	Epic 10S	Diolase 10S (K121327)
	Cervical conization Menorrhagia Ovarian cystectomy	Cervical conization Menorrhagia Ovarian cystectomy
	Neurosurgery:Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: Hemostasis in conjunction with meningiomas Percutaneous Disc Decompression (PLDD)	Neurosurgery:Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue, such as: Hemostasis in conjunction with meningiomas Percutaneous Disc Decompression (PLDD)
	Ophthalmology: Dacryocystorhinostomy transcanalicular Open DCR Tumor Excision Blepharoplasty	Ophthalmology: Dacryocystorhinostomy transcanalicular Open DCR Tumor Excision Blepharoplasty
	Pulmonary Surgery:Hemostasis, vaporization, and excision of tissue, such as: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction	Pulmonary Surgery:Hemostasis, vaporization, and excision of tissue, such as: Tracheobronchial malignancy or stricture Benign and malignant pulmonary obstruction
	Cardiac Surgery: Coagulation and hemostasis of cardiac tissue	Cardiac Surgery: Coagulation and hemostasis of cardiac tissue
	Thoracic Surgery: Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae	Thoracic Surgery: Thoracotomy Pulmonary resection Hemostasis Pericardiectomy Adhesiolysis Coagulation of blebs and bullae
	Urology:Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia	Urology:Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as: Vaporization of urethral tumors Release of urethral stricture Removal of bladder neck obstruction Excision and vaporization of condyloma Lesions of external genitalia
Descriptive	Epic 10S	Diolase 10S (K121327)
Information
	Vaporization of the prostate to treatbenign prostate hyperplasia (BPH) Dermatology/Aesthetics: Photocoagulation of vascular &dermatological lesions of the face andextremities Photocoagulation of telangiectasia,venulectasia of the legs and face Treatment of reticular veins andbranch varicosities Pyrogenic granuloma, lymphangiomaand lymphangiomatosis disease,angiofibromas Superficial benign vascular lesionsincluding Telangiectasias,hemangioma, Port wine stains,angiokeratoma, and benign epidermalpigment lesions as lentigines,epidermal nevi, spider nevi Dermatological surgery: Condylomaacuminate, warts, small non-malignant skin tumors, small semi-malignant tumors as basaliomas,Bowe, Kaposi sarcoma and wartyleucoplasty and ulcers debridement. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment Vascular Surgery: Photocoagulation of vascular &dermatological lesions of the face andextremities Photocoagulation of telangiectasia,veinulectasia of the legs and face	Vaporization of the prostate to treatbenign prostate hyperplasia (BPH) Dermatology/Aesthetics: Photocoagulation of vascular &dermatological lesions of the face andextremities Photocoagulation of telangiectasia,venulectasia of the legs and face Treatment of reticular veins andbranch varicosities Pyrogenic granuloma, lymphangiomaand lymphangiomatosis disease,angiofibromas Superficial benign vascular lesionsincluding Telangiectasias,hemangioma, Port wine stains,angiokeratoma, and benign epidermalpigment lesions as lentigines,epidermal nevi, spider nevi Dermatological surgery: Condylomaacuminate, warts, small non-malignantskin tumors, small semi-malignanttumors as basaliomas, Bowe, Kaposisarcoma and warty leucoplasty andulcers debridement. Seborrheic keratosis Mixoid cyst Papillary varix Acne treatment Vascular Surgery: Photocoagulation of vascular &dermatological lesions of the face andextremities Photocoagulation of telangiectasia,veinulectasia of the legs and face
	Treatment of reticular veins andbranch varicosities	Treatment of reticular veins andbranch varicosities
LaserClassification	IV (4)	IV (4)
Operating Voltage	100 - 240V ~ 1.5A	100V -240 ~ 2A
Laser Medium	InGaAsP	InGaAsP
Wavelength	940 ± 15nm	940 ± 15nm
Current Frequency	50 - 60 Hz	50 - 60 Hz
DescriptiveInformation	Epic 10S	Diolase 10S (K121327)
Max OutputPower	10 watts	10 watts
Power Mode	Continuous, Pulse Modulation	Continuous, Pulse Modulation
Pulse RepetitionRate	Up to 50 KHz	Up to 10 KHz ·
Pulse Duration	0.01 ms - 10 Seconds	0.06 ms - 10 Seconds
Aiming Beam	Laser Diode, max 1mW, 625 - 670nm, Class 3B	Laser Diode, max 3mW, 630 - 670nm, Class 3B
Materials	Medical grade plastics, steel, stainless steel,aluminum, brass, and electronic parts andcomponents	Medical grade plastics, steel, stainless steel,aluminum, brass, and electronic parts andcomponents

{4}------------------------------------------------

Section 5 - Page 6 of 10

{5}------------------------------------------------

Biolase – Epic 10S – 510(k) Submission

Section 5 - Page 7 of 10

{6}------------------------------------------------

Biolase – Epic 10S – 510(k) Submission

Section 5 - Page 8 of 10

{7}------------------------------------------------

Biolase - Epic 10S - 510(k) Submission

Section 5 - Page 9 of 10

.........

{8}------------------------------------------------

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 original 510(k) clearance under 510(k) No.: K121286. All indications included in this 510(k) have already been cleared by the FDA for an equivalent medical device manufactured by Biolase Technology, Inc.

Clinical Test Data

Clinical testing was not conducted on this device.

Conclusion

Based upon the comparison of the Epic 10S with the Diolose 10S previously cleared by the FDA, the clinical performance of the Epic 10S for the Indications for Use described above is deemed to be substantially equivalent to the legally-marketed predicate device, the Diolase 10S.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Biolase Technology, Incorporated % Ms. Colleen Boswell Vice President, Regulatory Affairs 4 Cromwell Irvine, California 92618-1816

April 11, 2013

Re: K130465

Trade/Device Name: Epic 10S 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: March 20, 2013 Received: March 21, 2013

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.

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-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{10}------------------------------------------------

Page 2 - Ms. Colleen Boswell

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours, FOR

Peter Diggimm -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{11}------------------------------------------------

Indications for Use

510(k) Number: K130465

Device Name: Epic10S

Indications for Use:

The Epic 10S is intended for use as a laser surgical instrument in general and plastic surgery and in dermatology. It is indicated for the following expanded Indications for Use:

Ear. Nose and Throat and Oral Surgery:

Hemostasis, incision, excision, ablation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity, such as:

l Removal of benign lesions from ear, nose and throat
. Excision and vaporization of vocal cord nodules and polyps
. Incision and excision of carcinoma in-situ
l Ablation and vaporization of hyperkeratosis
. Laryngeal papillectomy
. Excision and vaporization of herpes simplex 1 and II
. Neck dissection

Arthroscopy:

Hemostasis,incision,excision,vaporization,and ablation of joint tissues during arthroscopic surgery, such as:

. Menisectomy
. Syovectomy
. Chondromalacia

Gastroenterology:

Hemostasis, incision, excision, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy,such as:

. Hemostasis of upper and lower Glbleeding
Excision and vaporization of colorectal carcinoma l
. Excision of polyps
Hemostasis of colonoscopy ●
. Hemostasis of esophageal varices

Prescription Use × AND/OR Over-The-Counter Use (Part 21CFR 801Subpart D) (21CFR 807 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: 377
2013.04.11 11:0:33:55 -04:00:

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130465

{12}------------------------------------------------

Orthopedics:

. Dissect and coagulate

General Surgery, Dermatology & Plastic Surgery, and Podiatry:

Excision, ablation, vaporization, and photocoagulation of skin lesions hemostasis, incision, excision, vaporization, ablation,and debulking of soft tissue,abdominal,rectal,skin,fat or muscle tissue,and dermabrasion,such as:

� Matrixectomy
. Excision of neuromas
. Excision of periungual and subungual warts
Excision of plantar warts
Excision of Keloids
. Excision of cutaneous lesions
. Hemorrhoidectomy
Appendectomy
. Debridement of decubitus ulcer
Hepatobiliary
Mastectomy .
. Dermabrasion
Vaporization & hemostasis of capillary hemangioma .
. Excision, vaporization & hemostasis of abdominal tumors
Excision, vaporization & hemostasis of rectal pathology t
. Pilonidal cystectomy
. Herniorraphy
Adhesiolysis
. Parathyroidectomy
. laparoscopic cholecystecomy
Thyroidectomy ●
. Resection of organs

GI/GU:

Excision, vaporization, and hemostasis of abdominal and rectal tissues, such as:

. Hemorrhoidectomy
. Excision, vaporization, and hemostasis of rectal pathology
Excision, vaporization, and hemostasis of abdominal tumors

Prescription Use_X	AND/OR	Over-The-Counter Use_
(Part 21CFR 801Subpart 0)		(21CFR 807 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: 2013.04.11 10:34:18 304'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130465

{13}------------------------------------------------

Gynecology:

Ablation, excision, hemostasis, and vaporization of tissue, such as:

Excision or vaporization of condylomata acuminata .
. Vaporization of CIN (cervical intraepithelial neoplasia)
. Cervical conization
. Menorrhagia
. Ovarian cystectomy

Neurosurgery:

Vaporization, coagulation,excision,incision,ablation and hemostasis of tissue,such as:

l Hemostasis in conjunction with meningiomas
Percutaneous Disc Decompression (PLDD) l

Ophthalmology:

Dacryocystorhinostomy transcanalicular
l Open DCR
Tumor Excision o
Blepharoplasty .

Pulmonary Surgery:

Hemostasis, vaporization and excision oftissue, such as:

. Tracheobronchial malignancy or stricture
Benign and malignant pulmonary obstruction .

Cardiac Surgery:

. Coagulation and hemostasis of cardiac tissue

Thoracic Surgery:

Thoracotomy .
. Pulmonary resection
. Hemostasis
Pericardiectomy .
Adhesiolysis l
Coagulation of blebs and bullae l

Prescription Use X	AND/OR	Over-The-Counter Use
(Part 21CFR 801Subpart D)		(21CFR 807 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 2013.04 11 10:3 -04'00'

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130465

{14}------------------------------------------------

Urology:

Hemostasis, vaporization, incision, coagulation, ablation, and excision of tissues, such as:

. Vaporization of urethral tumors
. Release of urethral stricture
. Removal of bladder neck obstruction
. Excision and vaporization of condyloma
lesions of external genitalia .
. Circumcision
. Vaporization of the prostate to treat benign prostate hyperplasia (BPH)

Dermatology/Aesthetics:

Photocoagulation of vascular & dermatological lesions of the face and extremities .
Photocoagulation of telangiectasia, venulectasia of the legs and face .
. Treatment of reticular veins and branch varicosities
. Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
Superficial benign vascular lesions including Telangiectasias, hemangioma, Port wine stains, angiokeratoma, and benign epidermal pigment lesions as lentigines, epidermal nevi, spider nevi
. Dermatological surgery: Condyloma acuminate, warts, small non-malignant skin tumors, small semimalignant tumors as basaliomas, Bowe and Kaposisarcoma, warty leucoplasty and ulcers debridement
. Seborrheic keratosis
. Mixoid cyst
. Papillary varix
Acne treatment ●

Vascular Surgery:

t Photocoagulation of vascular & dermatological lesions of the face and extremities
. Photocoagulation of telangiectasia, veinulectasia of the legs and face
Treatment of reticular veins and branch varicosities t

Prescription Use _ X (Part 21CFR 801Subpart D) AND/OR

Over-The-Counter Use _ (21CFR 807 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 2013.04 11 11:0

(Division Sign-Off) for MXM Division of Surgical Devices 510(k) Number K130465

Biolase Epic IOS- SIO(k) Submission

Regulation Number and Section

§ 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.