K Number

Device Name

JOULE 810/940/980 MULTI-PLATFORM SYSTEM

Manufacturer

SCITON, INC.

Date Cleared

2013-06-19

(300 days)

Product Code

GEX

Regulation Number

878.4810

Intended Use

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.

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

K112031, K102036, K100558, K100143, K053628

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a laser system for various surgical and aesthetic applications. There is no mention of AI or ML in the intended use, device description, or any other section. The device appears to be a traditional laser delivery system.

Therapeutic

Yes.
The device is indicated for various medical treatments, including pain relief, tissue modification, and the treatment of vascular lesions, which are therapeutic applications.

Diagnostic

The device is indicated for surgical applications such as vaporization, incision, excision, ablation, cutting, coagulation, and photocoagulation of soft tissue, as well as hair removal and pain relief, none of which are diagnostic functions.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of a "console and laser deliver accessories" and uses "focusing optics to deliver thermal energy," indicating it is a hardware-based system that delivers optical energy.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
JOULE System's Function: The JOULE 810/940/980 Multi-Platform System is a laser system that delivers optical energy directly to soft tissue for surgical applications like vaporization, incision, excision, ablation, cutting, hemostasis, and coagulation. It also has indications for pain relief, hair removal, and treatment of vascular and pigmented lesions.
Lack of Specimen Analysis: The intended uses and device description clearly indicate that the device works directly on the patient's body and does not involve the analysis of in vitro specimens.

Therefore, the JOULE 810/940/980 Multi-Platform System falls under the category of a therapeutic or surgical device, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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 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

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, 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.

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 fipolysis.
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.

Product codes (comma separated list FDA assigned to the subject device)

GEX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue, face, extremities, legs, skin, muscle, joint, thigh, eye (blepharoplasty)

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)

Not Found

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K112031, K102036, K100558, K100143, K053628

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

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 Marketed
Predicate Device:	K112031: Alma Lasers Modified Diode Laser Module
K102036: LAMBDA S.p.A. Doctor Diode Laser Family
K100558: Quanta System QUANTA Diode Laser Family
K100143: CAO Group Pilot Diode Laser
K053628: Lumenis LightSheer Duet
Description of
JOULE 810/940/980
Multi-Platform System:	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.
Intended Use:	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

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.

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 (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

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.

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

| Specification | This Application
JOULE 810/940/980 Multi-Platform System | Alma Lasers
Modified Diode
Laser Module | LAMBDA S.p.A.
Doctor Diode Laser
Family | Predicate Devices
Quanta System
QUANTA Diode
Laser Family | CAO Group Pilot
Diode Laser | Lumenis
LightSheer Duet | Substantially
Equivalent |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|
| Indications for Use | General surgical applications.
Intended for hair removal and
treatment for benign
pigmented and vascular
lesions.
Temporary relief of muscle &
joint pain due to elevated
tissue temperature | General surgical
applications.
Intended for hair
removal and
treatment for benign
pigmented and
vascular lesions. | General surgical
applications.
Intended for hair
removal and
treatment for benign
pigmented and
vascular lesions. | General surgical
applications.
Intended for hair
removal and
treatment for benign
pigmented and
vascular lesions. | General surgical
applications.
Temporary relief of
muscle & joint pain
due to elevated
tissue temperature. | General surgical
applications.
Intended for hair
removal and
treatment for benign
pigmented and
vascular 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 |
| Electrical
Requirements | 230 VAC, 50/60 Hz, 1Φ | 120/230 VAC, 50/60
Hz, 1Φ | -- | 100-200VAC,
50/60Hz, 1Φ | -- | 110 - 240VAC
50/60 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 with
handpiece | Fiber optic with
handpiece | Fiber optic with
handpiece | Fiber optic with
handpiece | Fiber optic with
handpiece | Yes |
| User Interface | LCD touchscreen | LCD touchscreen | LCD touchscreen | LCD touchscreen | LCD touchscreen | LCD touchscreen | Yes |

Page 4 of 5

| Safety and
Effectiveness: | The indications for use are based upon the indications for use for predicate systems.
Technologically, the JOULE 810/940/980 Multi-Platform System is substantially
equivalent to the listed predicate devices. Therefore, the risks and benefits for the
JOULE 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, design
features, and similar functional features as, and therefore is substantially equivalent
to, the currently marketed predicate devices. |

. .

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

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

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

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

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)

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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

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