Ear, Nose and Throat and Oral Surgery: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissues from the ear, nose, throat and adjacent areas, including soft tissue in the oral cavity. Arthroscopy: Hemostasis, incision, excision, coagulation, vaporization, and ablation of joint tissues during arthroscopic surgery. Gastroenterology: Hemostasis, incision, excision, ablation, coagulation, and vaporization of tissue in the upper and lower gastrointestinal tracts via endoscopy. Orthopedics: Dissect and coagulate. General Surgery, Dematology & 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. GI/GU: Excision, vaporization, and hemostasis of abdominal and rectal tissues. Gynecology: Ablation, excision, incision, coagulation, hemostasis, and vaporization of tissue. Neurosurgery: Vaporization, coagulation, excision, incision, ablation and hemostasis of tissue. Ophthalmology: Dacryocystorhinostomy transcanalicular, Open DCR, Tumor Excision, Blepharoplasty. Pulmonary Surgery: Hemostasis, vaporization, coagulation, incision, ablation, and excision of tissue. 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. 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. 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, venulectasia of the legs and face, Treatment of reticular veins and branch varicosities.

Device Description

The Diolase™ 10S 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 Diolase™ 10S laser consists of two permanently connected components: Console, and Delivery System. The Console has a Control Panel (Touch Screen and Keypad) in front and a detachable base attached at the bottom rear of the Console. The Diolase™10S Laser Delivery System consists of the following: Fiber Optic Assembly and Surgical Handpiece.

AI/ML Overview

The provided document is a 510(k) summary for the Diolase™ 10S laser system, seeking expanded indications for use. This document asserts substantial equivalence to previously cleared devices rather than providing a performance study with acceptance criteria and results for the device itself.

Therefore, most of the requested information cannot be extracted from this document as it does not contain a study evaluating the device against specific acceptance criteria. Specifically, the document states: "Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices."

However, I can provide what can be inferred or directly stated from the document regarding the basis of its clearance for expanded indications.

Acceptance Criteria and Device Performance (Inferred/Stated Basis for Substantial Equivalence)

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness for new indications	Demonstrated through comparison to legally marketed predicate devices that already hold the requested indications. The Diolase™ 10S system is claimed to be "as safe, as effective, and will perform as well as the predicate devices."
Technological Characteristics Equivalence	The Diolase™ 10S system has the same technological characteristics (design, material, chemical composition, energy source) as the predicate devices. This equivalence underpins the assertion of similar safety and effectiveness.
Expanded Indications for Use (Specific Medical Procedures)	The requested additional indications (listed extensively in the "Indications for Use" section from page 2-4 and confirmed in the FDA letter and attached Indications for Use document from page 8-12) have been previously cleared by FDA for several equivalent medical devices, specifically K100558 (Quanta System QUANTA Diode Laser Family by Quanta System SpA) and K110375 (Blueshine GOLD Series by Blueshine srl), and the reference device K061898 (ezlase™ by Biolase Technology, Inc.) and K083069 (ezlase™ 10W by Biolase Technology, Inc.). The Diolase™ 10S is considered "substantially equivalent" to these predicates.

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No specific performance study with a test set was conducted for this 510(k) submission. The submission relies on substantial equivalence to predicate devices that already have these indications, implying that any required testing was done on the predicate devices.

2. 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)

Not applicable. No specific performance study with a test set was conducted.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No specific performance study with a test set was conducted.

4. 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

Not applicable. This device is a laser surgical instrument, not an AI/imaging device requiring MRMC studies.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a laser surgical instrument, not an algorithm. The 510(k) is for the physical device itself and its expanded indications for use.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No specific performance study with a ground truth was conducted for this submission. The "ground truth" for the expanded indications effectively comes from the regulatory clearance of the predicate devices based on their established safety and effectiveness.

7. The sample size for the training set

Not applicable. No new training set or performance study was involved in this 510(k) submission.

8. How the ground truth for the training set was established

Not applicable. No new training set or performance study was involved in this 510(k) submission.

Summary

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

K.121327

Biolase Technology, Inc.
Diolase™ Expanded Indication for Use

FEB 0 1 2013

510(k) Summary for Diolase™ 10S by Biolase Technology, Inc. (As required by 21CFR 807.92)

1. GENERAL INFORMATION

Date Prepared:

January 30, 2013

Company:

Biolase Technology, Inc. 4 Cromwell Irvine, CA 92618 Tel: (949) 361-1200 Fax: (949) 273-6687

Submitter:

Marcia VanValen Director of Business Development Tel: (949) 226-8159 e-mail: mvanvalen@biolase.net

Contact:

Colleen Boswell VP of Regulatory Affairs Tel: (949) 226-8470 e-mail: cboswell@biolase.net

2. NAMES / REGULATIONS

Trade/Device Name:	Diolase™ 10S
Common Name:	Diode Laser
Regulation Number:	21CFR 878.4810
Classification name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Regulatory Class:	II
Product Code:	GEX

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

3 ... PREDICATE DEVICES

ﯾ ﺩﺭ ﺍﯾ

(K100558) Quanta System QUANTA Diode Laser Family by Quanta System . SpA
(K110375) Blueshine GOLD Series by Blueshine srl .
Reference Device (K061898) ezlase™ by Biolase Technology, Inc. .
Reference Device (K083069) ezlase™ 10W by Biolase Technology, Inc. .

4. DEVICE DESCRIPTION

5. INDICATIONS FOR USE

Expanded Indications for Use:

Ear, Nose and Throat and Oral Surgery:

Hemostasis, incision, excision, ablation, coagulation, 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 papillomectomy .
Excision and vaporization of herpes simplex 1 and II
Neck dissection

Arthroscopy:

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

Menisectomy .
Syovectomy .
Chondromalacia

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

Gastroenterology:

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

Hemostasis of upper and lower GI bleeding .
Excision and vaporization of colorectal carcinoma .
Excision of polyps .
Hemostasis of colonoscopy ●
Hemostasis of esophageal varices ●

Orthopedics

. Dissect and coagulate

General Surgery, Dematology & 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 ●
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 .

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

Biolase Technology, Inc.
Diolase™ 10S Expanded Indication for Use

Gynecology:

CP-DEN 123

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

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

Neurosurgerv:

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, coagulation, incision, ablation, 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 t
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)

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

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 basalomas, Bowe, 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, venulectasia of the legs and face .
. Treatment of reticular veins and branch varicosities

6. DEVICE TECHNOLOGICAL CHARACTERISTICS

The Diolase "10 10S system has the same 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 predicate devices is included in the body of the 510(k) submission.

7. PERFORMANCE ASSESSMENT

Non-clinical performance data is not presented. Comparison with previously cleared devices is included in the body of the 510(k) submission for the demonstration of safety and effectiveness of the new indication of this device and to support substantial equivalence to legally marketed devices.

8. CONTRAINDICATIONS

The contraindications are identical to that of the previously cleared extase™ system by Biolase Technology, Inc.

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

Biolase Technology, Inc. Diolase™ 10S Expanded Indication for Use

All clinical procedures performed with Diolase™ 10S 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 510(k) submission is to add indications for use to the previously cleared ezlase™ diode laser system and market it as Diolase™ 10S. The requested additional indications have been cleared by FDA for several equivalent medical devices, including the following: K100558 (Quanta System QUANTA Diode Laser Family by Quanta System SpA) and K110375 (Blueshine GOLD Series by Blueshine srl). Based on comparison, the Diolase™ 10S system is substantially equivalent to previously cleared devices.

10. CONCLUSION

The indications requested by this 510(k) submission is the same as those previously cleared by FDA for other predicate devices. Substantial Equivalence for the Diolase™ 10S system has been determined through comparison to previous cleared devices. This summary demonstrates that the Diolase™ 10S system is as safe, as effective, and will perform as well as the predicate devices.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

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. Marcia Van Valen Director of Business Development 4 Cromwell Irvine, California 92618-1816

February 1, 2013

Re: K121327

Trade/Device Name: Diolase 10S Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: GEX Dated: January 02, 2013

Received: January 25, 2013

Dear Ms. Valen:

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 such 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); 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.

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

Page 2 - Ms. Marcia Van Valen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For

Peter D.,Rumm -S

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

Enclosure

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

Indications for Use

510(k) Number: K121327

Device Name: Diolase 10S

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:

Meniscectomy .
Synovectomy ●
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 GI bleeding •
. Excision and vaporization of colorectal carcinoma
◆ Excision of polyps
Hemostasis of colonoscopy .
Hemostasis of esophageal varices

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 2013.02.01 10:17:59 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K121327

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

Orthopedics

● Dissect and coagulate

General Surgery, Dematology & Plastic Surgery, and Podiatry:

Excision, ablation, vaporization, and photocoagulation of skin lesions, hemostasis, incision, 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
◆ Herniorrhaphy
. Adhesiolysis
. Parathyroidectomy
. Laparoscopic cholecystecomy
Thyroidectomy
Resection of organs

Prescription Use - X AND/OR Over-the-Counter Use (Part 21 CFR 801 Subpart D) (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 2013.02.01 ,10:19:05 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K121327

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

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

Neurosurgerv:

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 Surgerv:

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
Prescription Use X AND/OR Over-the-Counter Use (Part 21 CFR 801 Subpart D) (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 2013.02.01 10:19:56 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number K121327

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

Thoracic Surgery:

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

Urology:

Hemostasis, vaporization, incision, coagulation, 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 semi-malignant tumors as basaliomas, Bowe, Kaposi sarcoma. Warty leucoplasty and ulcers debridement.
Seborrheic keratosis .
. Mixoid cyst
Papillary varix .
. Acne treatment

Prescription Use	X	AND/OR	Over-the-Counter Use
(Part 21 CFR 801 Subpart D)			(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 2013.02.01 10:20:55 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number _ K121327

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

Vascular Surgery:

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 .

Prescription Use X Over-the-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (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 2013.02.01 ,10:22:04 -05'00'

(Division Sign-Off) Division of Surgical Devices 510(k) Number _ K121327

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.