The JOULE 810/940/980 Multi-Platform System (and delivery accessories used to deliver optical energy) are indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue.

The device is specifically indicated for use as follows:

810nm and 980nm
Dermatology/Aesthetics:

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
Pyrogenic granuloma, lymphangioma and lymphangiomatosis disease, angiofibromas
Superficial benign vascular lesions including Telangiectasias, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, 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 sarcom. Warty leucoplasty and ulcers debridment.
Seborrheic keratosis
Mixoid cyst
Papillary varix
Acne treatment
Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

Cut, coagulation & vaporization
Resurfacing
Blepharoplasty

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins

810nm
Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

The JOULE Multi-Platform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions, and the treatment for pseudofolliculitis barbae. It is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

940nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

980nm
The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

Dermatology, Plastic Surgery and Podiatry:
Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Excision of cutaneous lesions
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities
Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:
Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Device Description

The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliver accessories. It uses focusing optics to deliver thermal energy to the treatment site. The control console houses the power supply, cooling system, articulated arm delivery system and/or fiber optic arm delivery system with a handpiece. The user activates laser emission by means of a footswitch.

AI/ML Overview

The provided document is a 510(k) Summary for the JOULE 810/940/980 Multi-Platform System. This type of document establishes substantial equivalence to legally marketed predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical study or performance study for a novel device would.

Therefore, the Acceptance Criteria in this context are primarily based on demonstrating that the JOULE system's technological characteristics and intended uses are substantially equivalent to those of existing predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Based on Predicate Devices)	Reported Device Performance (JOULE 810/940/980 Multi-Platform System)	Met?
Indications for Use: General surgical applications; hair removal; treatment for benign pigmented and vascular lesions; temporary relief of muscle & joint pain due to elevated tissue temperature.	General surgical applications (vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue); hair removal; permanent hair reduction; treatment of benign pigmented and vascular lesions; temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature.	Yes
Wavelength: Similar to predicate devices (e.g., 810 nm, 940 nm, 980 nm, 1064 nm)	810, 940 & 980 nm	Yes
Fluence: Comparable to predicate devices (e.g., ≤ 120 J/cm2)	≤ 120 J/cm2	Yes
Max Power: Comparable to predicate devices (e.g., ≤ 100 W, ≤ 15 W, ≤ 30 W, 1600 W peak power)	≤ 100 W	Yes
Pulse Duration: Comparable to predicate devices (e.g., ≤ 1350 msec, ≤ 2500 msec, 5 - 400 msec)	≤ 2500 msec	Yes
Spot Size: Comparable to predicate devices (e.g., 1.2 cm2, 0.6 - 2.4 mm Ø, 22x35mm)	0.6mm Ø to 7.7 cm2	Yes
Output Mode: CW & pulsed mode	CW & pulsed mode	Yes
Repetition Rate: Comparable to predicate devices (e.g., ≤ 10 Hz, ≤ 200 Hz, 2.5 - 20,000 Hz, ≤ 3 Hz)	≤ 200 Hz	Yes
Laser Type: Diode	Diode	Yes
Electrical Requirements: Comparable to predicate devices (e.g., 230 VAC, 50/60 Hz, 1Φ)	230 VAC, 50/60 Hz, 1Φ	Yes
Console Dimensions: Comparable to predicate devices	16" x 30" x 43" high	Yes
Delivery System: Fiber optic with handpiece	Fiber optic with handpiece	Yes
User Interface: LCD touchscreen	LCD touchscreen	Yes

Study Proving Acceptance Criteria:

The "study" proving the device meets the acceptance criteria is a Substantial Equivalence (SE) determination based on a comparison to legally marketed predicate devices. This is not a traditional clinical trial or performance study in the sense of collecting new patient data. Instead, it's an analytical comparison.

2. Sample Size Used for the Test Set and Data Provenance:

Test Set Sample Size: Not applicable in the context of a 510(k) submission focused on substantial equivalence through comparison of technical specifications and intended uses. No an independent "test set" of patient data was used for this submission. The comparison is made against the established characteristics of already approved predicate devices.
Data Provenance: The data provenance is from the technical specifications and intended use statements of previously cleared 510(k) devices (K112031, K102036, K100558, K100143, K053628). This is retrospective in nature, as it relies on existing regulatory clearances and documented device designs. The country of origin of the data is implicitly the USA (FDA regulatory filings).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Number of Experts: Not applicable. Ground truth for a clinical "test set" is not established in this type of submission. The "ground truth" here is the established safety and effectiveness of the predicate devices as determined by the FDA in their original clearances. FDA reviewers (experts in medical devices) assess the substantial equivalence.
Qualifications of Experts: The experts would be the FDA reviewers from the Center for Devices and Radiological Health (CDRH)'s Office of Device Evaluation, specifically the Division of Surgical Devices, who are responsible for assessing 510(k) submissions. Their qualifications include expertise in medical device regulations, engineering, and medical science.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable. No clinical test set requiring adjudication was used. The adjudication process is the formal FDA review process to determine substantial equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed in imaging diagnostics to compare human reader performance with and without AI assistance. The JOULE system is a surgical laser, not an imaging diagnostic device that would involve human readers interpreting images.
Effect Size of Human Readers with vs. without AI: Not applicable for this device type and submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

Not applicable. The JOULE system is a physical laser device operated by a human, not an algorithm or AI system that would operate in a standalone manner without human intervention.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices, as acknowledged by their prior FDA clearances. The applicant is demonstrating that their new device is fundamentally similar in terms of technology and intended use, thus inheriting the "ground truth" of the predicates.

8. The Sample Size for the Training Set:

Training Set Sample Size: Not applicable. This submission does not involve machine learning or AI models that would require a training set. The device's design and performance are compared directly to predicate devices.

9. How the Ground Truth for the Training Set was Established:

Not applicable as there is no training set for this type of medical device submission.

Summary

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Attachment IV

510(k) Summary

Submitter:	Sciton, Inc.
Address:	925 Commercial Street, Palo Alto, CA 94303
Phone:	(650) 493-9155
Fax:	(650) 493-9146
Contact Person:	Jay M. Patel, VP of Regulatory Affairs
Date Prepared:	June 17, 2013
Device Trade Name:	JOULE 810/940/980 Multi-Platform System
Common Name:	Laser Powered Surgical Device (and Accessories)
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Legally MarketedPredicate Device:	K112031: Alma Lasers Modified Diode Laser ModuleK102036: LAMBDA S.p.A. Doctor Diode Laser FamilyK100558: Quanta System QUANTA Diode Laser FamilyK100143: CAO Group Pilot Diode LaserK053628: Lumenis LightSheer Duet
Description ofJOULE 810/940/980Multi-Platform System:	The JOULE 810/940/980 Multi-Platform System consist of a console and laser deliveraccessories. It uses focusing optics to deliver thermal energy to the treatment site.The control console houses the power supply, cooling system, articulated armdelivery system and/or fiber optic arm delivery system with a handpiece. Theuser activates laser emission by means of a footswitch.
Intended Use:	The JOULE 810/940/980 Multi-Platform System (and delivery accessories usedto deliver optical energy) are indicated for use in surgical applications requiringthe vaporization, incision, excision, ablation, cutting and hemostasis, orcoagulation of soft tissue.
	The device is specifically indicated for use as follows:
	810nm and 980nm
	Dermatology/Aesthetics:
	- Photocoagulation of vascular & dermatological lesions of the face andextremities- Photocoagulation of telangiectasia, veinulectasia 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, Rosacea,Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Portwine stains, angiokeratoma, and benign epidermal pigment lesions aslentigines. Epidermal nevi, spider nevi.- Dermatological surgery: Condyloma acuminate, warts, small nonmalignant skin tumors, small semi-malignant tumors as basalomas,Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.

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

Seborrheic keratosis
Mixoid cyst

ﺮ ﺰﺭ ﺍﻟ

Papillary varix
Acne treatment
Hair removal of unwanted hair from skin type I-V

Plastic Surgery:

Cut, coagulation & vaporization
Resurfacing
Blepharoplasty

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins

810nm

Temporary relief of minor muscle and joint pain, stiffness, minor arthritis pain, muscle spasm, temporary increase in local blood circulation, and temporary relaxation of muscles by means of topical elevated tissue temperature from infrared spectral emissions.

940nm

The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision/excision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (fumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

980nm

The JOULE Multi-Platform System (and their delivery accessories used to deliver optical energy) is indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue endovenous occlusion of the greater saphenous vein. The JOULE 980 System is further indicated for laser assisted lipolysis.

The device is specifically indicated for use as follows:

Dermatology, Plastic Surgery and Podiatry:

Excision, ablation, vaporization and photocoagulation of skin lesions, hemostasis, incision, excision, vaporization, ablation and debulking of soft tissue, abdominal, skin, fat or muscle tissue and dermabrasion. Examples include:

Matrixectomy
Excision of neuromas
Excision of periungual and subungual warts
Excision of plantar warts
Excision of keloids
Excision of cutaneous lesions
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities

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

Endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.
Treatment of reticular veins and branch varicosities

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:

Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Technological Characteristics: The JOULE 810/940/980 Multi-Platform System shares the same indications for use, and as noted below, shares similar design features (including wavelength, laser medium and delivery systems, power supply, cooling and control system), functional features (including power output, repetition rate, energy, spot size and fluence), and is therefore substantially equivalent to the above legally marketed predicate devices.

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

OFFICE
BUILDING
Param System Site
6040 Earle Brown Dr
Brooklyn Center, MN 55430

Specification	This ApplicationJOULE 810/940/980 Multi-Platform System	Alma LasersModified DiodeLaser Module	LAMBDA S.p.A.Doctor Diode LaserFamily	Predicate DevicesQuanta SystemQUANTA DiodeLaser Family	CAO Group PilotDiode Laser	LumenisLightSheer Duet	SubstantiallyEquivalent
Indications for Use	General surgical applications.Intended for hair removal andtreatment for benignpigmented and vascularlesions.Temporary relief of muscle &joint pain due to elevatedtissue temperature	General surgicalapplications.Intended for hairremoval andtreatment for benignpigmented andvascular lesions.	General surgicalapplications.Intended for hairremoval andtreatment for benignpigmented andvascular lesions.	General surgicalapplications.Intended for hairremoval andtreatment for benignpigmented andvascular lesions.	General surgicalapplications.Temporary relief ofmuscle & joint paindue to elevatedtissue temperature.	General surgicalapplications.Intended for hairremoval andtreatment for benignpigmented andvascular lesions.	Yes
Ref. 510(k)	N/A	K112031	K102036	K100558	K100143	K053628	--
Wavelength	810, 940 & 980 nm	810 nm	810, 940, 980 &1064 nm	532, 810, 940, 980,1064, 1320, 1470,1950 nm	810 nm	790 - 950 nm(800 nm nominal)	Yes
Fluence	≤ 120 J/cm2	≤ 120 J/cm2	--	--	--	10 - 100 J/cm2	Yes
Max Power	≤ 100 W	≤ 100 W	≤ 15 W	≤ 30 W	≤ 15 W	1600 W peak power	Yes
Pulse Duration	≤ 2500 msec	≤ 1350 msec	--	≤ 2500 msec	--	5 - 400 msec	Yes
Spot Size	0.6mm Ø to 7.7 cm2	1.2 cm2	--	0.6 - 2.4 mm Ø	--	22x35mm(7.7 cm2)	Yes
Output Mode	CW & pulsed mode	CW & pulsed mode	CW & pulsed mode	CW & pulsed mode	CW & pulsed mode	CW & pulsed mode	Yes
Repetition Rate	≤ 200 Hz	≤ 10 Hz	--	≤ 200 Hz	2.5 - 20,000 Hz	≤ 3 Hz	Yes
Laser Type	Diode	Diode	Diode	Diode	Diode	Diode	Yes
ElectricalRequirements	230 VAC, 50/60 Hz, 1Φ	120/230 VAC, 50/60Hz, 1Φ	--	100-200VAC,50/60Hz, 1Φ	--	110 - 240VAC50/60 Hz. 1 Ф	Yes
Console Dimensions	16" x 30" x 43" high	20" x 23" x 47" high	--	16" x 13" x 10" high	--	17" x 20" x 44" high	Yes
Delivery System	Fiber optic with handpiece	Fiber optic withhandpiece	Fiber optic withhandpiece	Fiber optic withhandpiece	Fiber optic withhandpiece	Fiber optic withhandpiece	Yes
User Interface	LCD touchscreen	LCD touchscreen	LCD touchscreen	LCD touchscreen	LCD touchscreen	LCD touchscreen	Yes

Page 4 of 5

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

Safety andEffectiveness:	The indications for use are based upon the indications for use for predicate systems.Technologically, the JOULE 810/940/980 Multi-Platform System is substantiallyequivalent to the listed predicate devices. Therefore, the risks and benefits for theJOULE 810/940/980 Multi-Platform System are comparable to the predicate devices.
Conclusion:	JOULE 810/940/980 Multi-Platform System shares similar indications for use, designfeatures, and similar functional features as, and therefore is substantially equivalentto, the currently marketed predicate devices.

. .

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

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

June 19, 2013

Sciton, Inc. % Mr. Jay M. Patel 925 Commercial Street Palo Alto, California 94303

Re: K122567

Trade/Device Name: Joule 810/940/980 Multi-Platform System 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: May 31, 2013 Received: June 04, 2013

Dear Mr. Patel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

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

Page 2 - Mr. Jay M. Patel

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ycm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

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

Attachment II

Statement of Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ K422567

JOULE 810/940/980 Multi-Platform System Device Name:

Indications for Use:

The JOULE 810/940/980 Multi-Platform System (and delivery accessories used to deliver optical energy) is indicated for use in surgical applications requiring the vaporization, incision, ablation, cutting and hemostasis, or coagulation of soft tissue.

The device is specifically indicated for use as follows:

810nm and 980nm

Dermatology/Aesthetics:

Photocoagulation of vascular & dermatological lesions of the face and ﮯ extremities
Photocoagulation of telangiectasia, veinulectasia 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, Rosacea, Angioma, venous lakes Couperosis, Cherry angioma, hemangioma, Port wine stains, angiokeratoma, and benign epidermel pigment lesions as lentigines. Epidermal nevi,
spider nevi. - Dermatological surgery: Condyloma acuminate, warts, small non malignant skon
tumors, small semi-malignant tumors as basalomas, Bowe, Kaposi sarcom. Warty leucoplasty and ulcers debridment.
Seborheic keratosis
Mixoid cyst
Papillary varix
Acne treatment
Hair removal of unwanted hair from skin type I-V .

Plastic Surgery:

Cut. coaculation & vaporization .
Resurfacing
Blepharopiasty

Vascular Surgery:

Endoluminal or endovenous laser surgery for saphenous incompetent veins
Prescription Use × (Per 21CFR801)

Over-The-Counter Use

21CFR801)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.06.18 16:11:45 -04'00"

(Division Sign-Off) for MXM

Oivision of Surgical Devices

510(k) Number_K122567

Page 1 of 3

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

810nm

The JOULE Multi-Platform System is indicated for the treatment of vascular lesions, including angiomas, hemangiomas, telanglectasia and other benign vascular lesions, and the treatment for pseudofollicultis barbae. It is also indicated for hair removal, permanent hair reduction, and the treatment of benign pigmented lesions and leg veins. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

940nm

The JOULE Multi-Plation System (and their delivery accessories used to deliver optical energy) are intended for use in cutting, vaporization, ablation and coagulation of soft tissue in conjunction with endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, gastroscopes, cystoscopes, and colonoscopies), in incision, vaporization, ablation and coagulation of soft tissue in contact and non-contact open surgery (with or without a handpiece), in the treatment and/or removal of vascular lesions (tumors) and removal of unwanted hair, and for endovascular coagulation of the greater saphenous vein of the thigh in patients with superficial vein reflux.

Prescription Use × Over-The-Counter Use

(Per 21CFR801)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.06.18 16:12:16 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number _K122567

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

980am

The device is specifically indicated for use as follows:

Dermatology, Plastic Surgery and Podiatry:

Matrixectomy .
Excision of neuromas
Excision of periungual and subungual warts -
Excision of plantar warts
Excision of keloids
Excision of cutaneous lesions
Dermabrasion
Vaporization and hemostasis of capillary hemangioma
Debridement of wounds
Photocoagulation of teleangectasia of the legs and face
Photocoagulation of vascular lesions of the face and extremities .
Endovascular coagulation of the greater saphenous vein of the thigh in patients with . superficial vein reflux.
Treatment of reticular veins and branch varicosities

Endovenous Occlusion of the Greater Saphenous Vein in Patients with Superficial Vein Reflux:

Indicated for use with their delivery accessories in the endovascular coagulation of the Greater Saphenous Vein (GSV) of the thigh in patients with Superficial Vein Reflux.

Over-The-Counter Use Prescription Use OR × (Per 21CFR801)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R Ogden 2013.06.18 16:12:47 -04'00'

(Division Sign-Off) for MXM

Division of Surgical Devices

510(k) Number_ K122567

Page 3 of 3

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.