The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.
Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos
The 1064 nm Nd:YAG Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea. Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB). Treatment of facial wrinkles. The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.
Q-Switched 1064/532 nm Nd: YAG Indications for Use: The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses; Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Nevus of Ota Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 532 nm wavelength Tattoo Removal (light ink: yellow, red, light blue, green) Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
The 1319 nm Nd:YAG Indications for Use: Treatment of fine lines and wrinkles. Treatment of atrophic acne scars. Treatment of mild to moderate inflammatory acne vulgaris. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.
1470 nm Indications for Use: The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coaqulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
1550 nm Indications for Use: The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
2940 nm Indications for Use: The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation. The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue.
BBL (300-1400nm) Indications for Use: The Joule Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dematology. It is intended for use for: Mild to moderate inflammatory and pustular inflammatory acne vulgaris. (420nm BP filter, 515nm LP filter, 560 LP filter) The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter) The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter) The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter) The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter) Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP filter) The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment: Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Device Description

The JOULE Multi-Platform System is a modular, multi-wavelength laser/light system. The system uses scanning and focusing optics to deliver a pattern of thermal energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner.

AI/ML Overview

This document, a 510(k) Summary for the JOULE Multi-Platform System, is a pre-market notification to the FDA. It asserts substantial equivalence to legally marketed predicate devices, rather than providing a detailed study that proves the new device meets specific acceptance criteria based on performance data.

Therefore, many of the requested details about a study for proving acceptance criteria cannot be extracted from this document, as it describes the device and its intended uses and argues for equivalence, not a performance study against acceptance criteria for a novel algorithm or AI.

However, I can extract information related to the device's intended uses and the basis of its substantial equivalence.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Assertion, Not a Performance Study):

This document does not present specific quantitative acceptance criteria or detailed performance results in the way a clinical trial or algorithm validation study would. Instead, it asserts "substantial equivalence" to existing legally marketed predicate devices. The "performance" is implicitly deemed acceptable if it is comparable to the predicate devices and meets its described indications for use.

Acceptance Criterion Type (Implied)	Reported Device Performance (Implied via Substantial Equivalence)
Safety (Comparable to Predicate Devices)	The JOULE Multi-Platform System (System) is asserted to have comparable risks and benefits to its predicate devices due to shared indications for use, similar design features (wavelength, laser/light medium, delivery systems, power supply, cooling, control), and functional features (power output, repetition rate, energy, spot size, fluence). This implies it meets the safety profile of the predicate devices.
Effectiveness (Comparable to Predicate Devices for listed Indications)	The System is asserted to be substantially equivalent to currently marketed predicate devices, implying its effectiveness for the claimed indications is comparable. These indications include:
	- 755 nm Alexandrite: Stable long-term or permanent hair reduction (all skin types including tanned), vascular lesions, benign pigmented lesions, wrinkles.
	- Q-Switched 755 nm Alexandrite: Pigmented lesions, tattoos.
	- 1064 nm Nd:YAG: Coagulation/hemostasis of benign vascular lesions (telangiectasias, rosacea), unwanted hair removal, PFB treatment, facial wrinkles, laser-assisted lipolysis.
	- Q-Switched 1064/532 nm Nd:YAG: Incision, Excision, Ablation, Vaporization, Coagulation, Hemostasis of soft tissue for general/dermatologic/general surgical procedures. Specific: 1064nm for dark tattoo removal, Nevus of Ota, hair removal/lightening, skin resurfacing (acne scars, wrinkles), benign cutaneous lesions (striae, scars), reduction of red pigmentation in scars. 532nm for light tattoo removal, vascular lesions (port wine stains, telangiectasias, spider angiomas, etc.), epidermal pigmented lesions (Cafe-au-lait, solar lentiginos, freckles, etc.), other pigmented cutaneous lesions (verrucae, skin tags, keratoses, plaques), skin resurfacing (acne scars, wrinkles), benign cutaneous lesions (striae, scars), reduction of red pigmentation in scars.
	- 1319 nm Nd:YAG: Fine lines and wrinkles, atrophic acne scars, mild to moderate inflammatory acne vulgaris, laser-assisted lipolysis, treatment of reflux of great and small saphenous veins associated with varicose veins/varicosities, and incompetence/reflux of superficial veins in lower extremity.
	- 1470 nm: Delivery of laser light to soft tissue for incision, excision, vaporization, ablation, hemostasis or coagulation. Treatment of reflux of saphenous veins associated with varicose veins/varicosities. ProFractional handpiece: dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
	- 1550 nm: ProFractional handpiece: dermatological procedures requiring skin resurfacing and coagulation of soft tissue.
	- 2940 nm: Surgical applications (excision, incision, ablation, vaporization, coagulation of soft tissue), skin resurfacing. Aesthetic Surgery: skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, decubitis ulcers, laser assisted site preparation for hair transplantation. ProFractional handpiece: dermatological procedures requiring skin resurfacing, ablation, and coagulation of soft tissue.
	- BBL (300-1400nm): Surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in general/plastic surgery and dermatology. Specific: Mild to moderate inflammatory/pustular inflammatory acne vulgaris; benign pigmented lesions (dyschromia, hyperpigmentation, melasma, ephelides); cutaneous lesions (warts, scars, striae); benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins, venous malformations); unwanted hair removal/stable long-term/permanent hair reduction; topical heating for temporary relief of minor muscle/joint pain/stiffness, temporary relief of minor joint pain associated with arthritis, temporary increase in local circulation, muscle relaxation, muscle spasms, minor sprains/strains, minor muscular back pain.
Integral Thermo-Electric Cooler Performance (Implied via Substantial Equivalence)	Reduces pain/discomfort during/after light/laser treatment (via partial anesthesia). Minimizes thermal injury to non-target skin, reducing complications (scabbing, scarring, hyper/hypopigmentation). Allows use of higher light/laser fluences. Reduces potential side effects of light/laser treatments.

Details Regarding the "Study" (Basis for Substantial Equivalence):

The document describes a comparison study to predicate devices for the purpose of demonstrating substantial equivalence, rather than a standalone clinical performance study of the JOULE Multi-Platform System itself against specific acceptance criteria. This is typical for a 510(k) submission.

Sample size used for the test set and data provenance:
- Test Set Sample Size: Not applicable in the context of a performance study with a 'test set.' The submission relies on comparative analysis against the characteristics and indications of existing predicate devices. No specific patient or image test set is mentioned for the JOULE system's performance validation itself.
- Data Provenance: Not applicable in the context of a performance study. The data provenance refers to the regulatory clearances (K-numbers) of previously approved predicate devices, which are legally marketed in the USA. The data itself would have come from the original studies for those predicate devices, but these are not detailed here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The document is a 510(k) summary demonstrating substantial equivalence based on technical characteristics and intended use, not a clinical study requiring expert-established ground truth for a novel device's performance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no mention of a test set or adjudication for performance evaluation in this 510(k) summary.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done or described in this document. The comparison is not about human readers with or without AI assistance. It's a technical and indications-based comparison of a new laser system to prior laser systems.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a laser/light system, not an algorithm or AI. No standalone algorithm performance study is relevant or described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth in the context of a performance study is described. The "truth" here is essentially the FDA's prior determination that the predicate devices are safe and effective for their stated indications.
The sample size for the training set:
- Not applicable. This is not an AI/algorithm device that requires a training set.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/algorithm device that requires a training set.

Summary

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长101916

MAR 1 8 2011

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:	March 16, 2011
Device Trade Name:	JOULE Multi-Platform System
Common Name:	Laser/Light Powered Surgical Device (and Accessories)
Classification Name:	Laser Surgical Instrument, 21 CFR 878.4810.
Legally MarketedPredicate Device:	755 nm Laser SystemK081352: Profile Multi-Platform SystemQ-Switched 755 nm AlexK081324: Candela Family of Q-Switched AlexandriteK072868: Cynosure Accolade II Laser1064 nm Laser SystemK070388: Profile Multi-Platform SystemK060033: Profile Multi-Platform SystemK023881: Profile 1064 Laser SystemQ-Switched 1064/532 nm Nd:YAGK083899: Hoya ConBio RevLite Q-Switched Nd:YAG Laser SystemK072564: Alma Harmony XL Multi-Platform Q-Switched Nd:YAGK050382: Cynosure Affinity QS Q-Switched Nd:YAG Laser System1319 nm Laser SystemK081352: Sciton Profile Multi-Platform SystemK070388: Sciton Profile Multi-Platform SystemK060033: Sciton Profile Multi-Platform System1470 nm Laser SystemK083613: Quanta System Polysurge Diode Laser FamilyK082230: Xintec Vectra Family of Laser Systems and AccessoriesK082225: Biolitec Ceralas D 1470 nm Diode Laser1470 nm Laser System (Fractional)K101506: Palomar Lux 1440K090195: Palomar Lux1540K070284: Reliant Technologies Fraxel SR1500 Laser System1550 nm Laser System (Fractional)K090195: Palomar Lux1540K070284: Reliant Technologies Fraxel SR1500 Laser System2940 nm Laser System (Fractional)K081352: Sciton Profile Multi-Platform SystemK070388: Profile Multi-Platform SystemK060033: Profile Multi-Platform SystemK100270: Palomar LUX2940BBL SystemK070388: Sciton Profile Multi-Platform SystemK060033: Sciton Profile Multi-Platform SystemK042165: Cutera TitanK042630: RevLight Skin Care System

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Description of The JOULE Multi-Platform System is a modular, multi-wavelength laser/light system. JOULE Multi-Platform The system uses scanning and focusing optics to deliver a pattern of thermal System: energy to the treatment site. The system consists of control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner. Intended Use: The 755 nm Alexandrite system is designed for use in: The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles. Q-Switched 755 nm Alexandrite Indications for Use: The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos The 1064 nm Nd:YAG Indications for Use: Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea. Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB). Treatment of facial wrinkles. The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis. Q-Switched 1064/532 nm Nd: YAG Indications for Use: The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses; Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength Tattoo Removal (dark ink: blue and black) Nevus of Ota Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. 532 nm wavelength Tattoo Removal (light ink: yellow, red, light blue, green) Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques Skin Resurfacing for Acne Scars and Wrinkles Benign Cutaneous Lesions, such as, but not limited to: striae and scars

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Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The 1319 nm Nd:YAG Indications for Use:

Treatment of fine lines and wrinkles.

Treatment of atrophic acne scars.

Treatment of mild to moderate inflammatory acne vulgaris.

The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.

The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for the treatment of reflux of great and small saphenous veins associated with varicose veins and varicosities, and for treatment of incompetence and reflux of superficial veins in the lower extremity.

1470 nm Indications for Use:

The JOULE 1470 nm Multi-Platform Systems and delivery accessories are intended for delivery of laser light to soft tissue for use in incision, excision, vaporization, ablation, hemostasis or coaqulation of soft tissue. The device is indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.

The JOULE 1470 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

1550 nm Indications for Use:

The JOULE 1550 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

2940 nm Indications for Use:

The JOULE 2940 nm Multi-Platform Systems with delivery accessories are designed for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue, and for skin resurfacing. Aesthetic Surgery: Skin resurfacing and treatment of wrinkles. Dermatology & Plastic Surgery: Indications include epidermal nevi, actinic cheilitis, keloids, verrucae, skin tags, anal tags, keratoses, scar revision, debulking benign tumors, and decubitis ulcers. It is also used for laser assisted site preparation for hair transplantation.

The JOULE 2940 nm Multi-Platform Systems with ProFractional handpiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing, and ablation and coagulation of soft tissue.

BBL (300-1400nm) Indications for Use:

The Joule Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dematology.

It is intended for use for:

· Mild to moderate inflammatory and pustular inflammatory acne vulgaris.
- (420nm BP filter, 515nm LP filter, 560 LP filter)
· The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter)
· The treatment of cutaneous lesions including warts, scars and striae; (515nm LP filter, 560nm LP filter)
· The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias,

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

rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter)

· The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter)
Topical heating for the purpose of elevating tissue temperature for the . temporary relief of minor muscle and ioint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP filter)

The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);

Reduce discomfort during and/or associated with light or laser treatment:

Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- and/or hypopigmentation;

Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and

Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

The JOULE Multi-Platform System shares the same indications for use, similar design features (including wavelength, laser/light 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.

The indications for use are based upon the indications for use for predicate systems. Technologically, the JOULE Multi-Platform System is substantially equivalent to the listed predicate devices. Therefore, the risks and benefits for the JOULE Multi-Platform System are comparable to the predicate devices.

Conclusion:

Safety and

Effectiveness:

Technological

Characteristics:

The JOULE 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.

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Image /page/4/Picture/1 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 symbol that resembles an abstract human figure or a caduceus, composed of three curved lines.

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

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

MAR 1 8 2011

Re: K101916

Trade/Device Name: JOULE 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, ONG, ORK, ONF Dated: March 17, 2011

Received: March 17, 2011

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.

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Page 2 – Mr. Jay M. Patel

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 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/MedicalDevices/Safety/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aty B. nh
for

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment III

Statement of Indications for Use

JOULE Multi-Platform System

510(k) Number (if known): K101916

Indications for Use:

Device Name:

The 755 nm Alexandrite system is designed for use in:

The ClearScan ALX 755nm Alexandrite laser system with its accessories is indicated for stable long-term, or permanent hair reduction for all skin types (Fitzpatrick I - VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions and wrinkles.

Q-Switched 755 nm Alexandrite Indications for Use:

The JOULE Q-Switched 755 nm Alex Multi-Platform Systems with accessories are indicated for the following uses: Pigmented Lesions Tattoos

The 1064 nm Nd:YAG Indications for Use:

Coagulation and hemostasis of benign vascular lesions such as, but not limited to, telangiectasias and rosacea.

Removal of unwanted hair (for stable, long term or permanent hair reduction) through selective targeting of melanin in hair follicles and for the treatment of Pseudofolliculitis Barbae (PFB).

Treatment of facial wrinkles.

The JOULE 1064 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.

Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Per 21CFR801)

OR Over-The-Counter Use

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

Neil R. Udelon for maxim

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 5

:10(k) Number K101916

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Q-Switched 1064/532 nm Nd: YAG Indications for Use:

The JOULE Q-Switched 1064/532 nm Nd:YAG Multi-Platform Systems with accessories are indicated for the following uses:

Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatologic and General Surgical Procedures for Coagulation and Hemostasis.

Specific Indications:

1064 nm wavelength

Tattoo Removal (dark ink: blue and black)

Nevus of Ota

Removal or lightening of hair with or without adjuvant preparation Skin Resurfacing for Acne Scars and Wrinkles

Benign Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

532 nm wavelength

Tattoo Removal (light ink: yellow, red, light blue, green)

Vascular Lesions including but not limited to: port wine stains/birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi

Epidermal Pigmented Lesions including but not limited to: Cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus

Other Pigmented Cutaneous Lesions including verrucae, skin tags, keratoses and plaques

Skin Resurfacing for Acne Scars and Wrinkles

Benian Cutaneous Lesions, such as, but not limited to: striae and scars Reduction of Red Pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.

The 1319 nm Nd:YAG Indications for Use:

Treatment of fine lines and wrinkles.

Treatment of atrophic acne scars.

Treatment of mild to moderate inflammatory acne vulgaris.

The JOULE 1319 nm Nd:YAG with fiber delivery is indicated for laser assisted lipolysis.

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)	Nekeda for nxm
	(Division Sign-Off)
	Division of Surgical, Orthopedic,
Page 2 of 5	and Restorative Devices

· 510(k) Number

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1470 nm Indications for Use:

The JOULE 1470 nm Multi-Platform Systems with ProFractional handbiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

1550 nm Indications for Use:

The JOULE 1550 nm Multi-Platform Systems with ProFractional handbiece and delivery system is intended for use in dermatological procedures requiring skin resurfacing and coagulation of soft tissue.

2940 nm Indications for Use:

Nifredde formxn

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101916

Prescription Use × (Per 21CFR801)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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

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BBL (300-1400nm) Indications for Use:

The JOULE Multi-Platform Systems and Accessories are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.

It is intended for use for:

· Mild to moderate inflammatory and pustular inflammatory acne vulgaris.
(420nm BP filter, 515nm LP filter, 560 LP filter)
· The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) (515nm LP filter, 560nm LP filter)
· The treatment of cutaneous lesions including warts, scars and striae:

(515nm LP filter, 560nm LP filter)

· The treatment of benign cutaneous vascular lesions, including port wine stains, hemanqiomas, facial, truncal and leg telangjectasias. rosacea, erythema of rosacea, angiomas and spider angiomas. poikiloderma of Civatte, leg veins and venous malformations; (560nm LP filter, 590nm LP filter)
· The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction (590nm LP filter, 640nm LP filter, 695 LP filter)
· Topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain. (800 nm LP Filter)

Reduce pain during and/or associated with light or laser treatment (via partial anesthesia from cooling);

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

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

	Nuk K. Ogles Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices
	Page 4 of 5
510(k) Number	K101916

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Reduce discomfort during and/or associated with light or laser treatment;

Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and

Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Neil R.P. Isle for mkr
Division of 88

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K101916

Prescription Use X (Per 21CFR801)

OR Over-The-Counter Use

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

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.