K Number

Device Name

EPIC 10S

Manufacturer

BIOLASE TECHNOLOGY, INC.

Date Cleared

2013-04-11

(45 days)

Product Code

GEX

Regulation Number

878.4810

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, 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K121327

Reference Devices

K121286

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description focuses on the laser technology and its delivery system, with no mention of AI or ML capabilities, image processing, or data sets typically associated with AI/ML development. The 510(k) is for expanding indications based on a predicate device, not for introducing new technological features like AI/ML.

Therapeutic

Yes.
The device is specifically intended for use as a laser surgical instrument in various medical specialties for therapeutic procedures.

Diagnostic

The device is described as a "laser surgical instrument" intended for various surgical and dermatological procedures to "emit laser energy" and treat target sites. Its function is interventional/therapeutic, not diagnostic.

SaMD (Software as a Medical Device)

The device description clearly outlines hardware components including a laser diode, fiber optic cable, handpiece, base console, delivery system, tips, and a wireless footswitch. This is not a software-only device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's a "laser surgical instrument" for various surgical procedures on the human body. IVDs are used to examine specimens (like blood, urine, tissue) outside of the body to diagnose diseases or conditions.
Device Description: The description details a laser system that emits energy to a target site on the patient. This is a therapeutic or surgical device, not a diagnostic one that analyzes samples.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

The device is a surgical laser intended for direct use on a patient's body for treatment purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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:

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
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

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

Product codes

GEX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear, Nose, Throat, Oral Cavity, Joint, Upper and Lower Gastrointestinal Tracts, Skin, Abdominal, Rectal, Fat, Muscle Tissue, Cervical, Meninges, Disc, Eye, Tracheobronchial, Lungs, Cardiac, Thorax, Urethra, Bladder, External Genitalia, Prostate, Face, Extremities, Legs.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K121327

Reference Device(s)

K121286

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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:

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

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

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

| Descriptive

Information	Epic 105	Diolase 10S (K121327)
Company	Biolase Technology, Inc.	Biolase Technology, Inc.
Descriptive
Information	Epic 105	Diolase 10S (K121327)
	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:	The Diolase 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:	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:
	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 during
arthroscopic surgery, such as:	Arthroscopy:
Hemostasis, incision, excision, vaporization,
and ablation of joint tissues during
arthroscopic surgery, such as:
	Menisectomy Syovectomy Chondromalacia	Menisectomy Syovectomy Chondromalacia
	Gastroenterology:
Hemostasis, incision, excision, and
vaporization of tissue in the upper and lower
gastrointestinal tracts via endoscopy, such as:	Gastroenterology:
Hemostasis, incision, excision, and
vaporization of tissue in the upper and lower
gastrointestinal 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, and
photocoagulation of skin lesions, hemostasis,	Orthopedics:
Dissect and coagulate General Surgery, Dermatology & Plastic
Surgery, and Podiatry:
Excision, ablation, vaporization, and
photocoagulation of skin lesions, hemostasis,
Descriptive
Information	Epic 10S	Diolase 10S (K121327)
	incision, excision, vaporization, ablation, and
debulking of soft tissue, abdominal, rectal,
skin, fat or muscle tissue, and dermabrasion,
such as:	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 Pilonidal cystectomy Herniorraphy Adhesiolysis Parathyroidectomy Laparoscopic cholecystecomy Thyroidectomy Resection of organs	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 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	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)	Gynecology:
Ablation, excision, hemostasis, and
vaporization of tissue, such as:
Excision or vaporization of
condylomata acuminata Vaporization of CIN (cervical
intraepithelial neoplasia)
Descriptive
Information	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 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 semi-
malignant tumors as basaliomas,
Bowe, Kaposi sarcoma and 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	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 semi-malignant
tumors as basaliomas, Bowe, Kaposi
sarcoma and 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	Treatment of reticular veins and
branch varicosities
Laser
Classification	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
Descriptive
Information	Epic 10S	Diolase 10S (K121327)
Max Output
Power	10 watts	10 watts
Power Mode	Continuous, Pulse Modulation	Continuous, Pulse Modulation
Pulse Repetition
Rate	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 and
components	Medical grade plastics, steel, stainless steel,
aluminum, brass, and electronic parts and
components

Section 5 - Page 6 of 10

Biolase – Epic 10S – 510(k) Submission

Section 5 - Page 7 of 10

Biolase – Epic 10S – 510(k) Submission

Section 5 - Page 8 of 10

Biolase - Epic 10S - 510(k) Submission

Section 5 - Page 9 of 10

.........

Non-Clinical Test Data

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.

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

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

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

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

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

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