Who is the manufacturer of JOULE 810/940/980 MULTI-PLATFORM SYSTEM?

Sciton, Inc filed the 510(k) submission for JOULE 810/940/980 MULTI-PLATFORM SYSTEM (K122567).

What is the FDA product code for JOULE 810/940/980 MULTI-PLATFORM SYSTEM?

GEX. It is classified under 21 CFR 878.4810 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for JOULE 810/940/980 MULTI-PLATFORM SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for JOULE 810/940/980 MULTI-PLATFORM SYSTEM?

Alma Lasers Modified Diode Laser Module (K112031); LAMBDA S.p.A. Doctor Diode Laser Family (K102036); Quanta System QUANTA Diode Laser Family (K100558); CAO Group Pilot Diode Laser (K100143); Lumenis LightSheer Duet (K053628).

Who can help prepare an FDA 510(k) submission like JOULE 810/940/980 MULTI-PLATFORM SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

JOULE 810/940/980 MULTI-PLATFORM SYSTEM

K122567 · Sciton, Inc · GEX · Jun 19, 2013 · General, Plastic Surgery

Device Facts

Record ID	K122567
Device Name	JOULE 810/940/980 MULTI-PLATFORM SYSTEM
Applicant	Sciton, Inc
Product Code	GEX · General, Plastic Surgery
Decision Date	Jun 19, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4810
Device Class	Class 2
Attributes	Therapeutic

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.

Device Story

JOULE 810/940/980 Multi-Platform System is a laser-powered surgical device consisting of a console, power supply, cooling system, and delivery accessories (fiber optic arm/handpiece). Device delivers thermal energy to soft tissue via 810nm, 940nm, or 980nm laser wavelengths. Operated by clinicians in clinical settings via footswitch activation. System uses focusing optics to perform vaporization, incision, excision, ablation, and coagulation. Output is controlled via LCD touchscreen interface. Clinical benefits include precise tissue management, vascular lesion treatment, hair reduction, and endovenous occlusion. Device supports various surgical specialties including dermatology, plastic surgery, and vascular surgery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and indications for use with legally marketed predicate devices.

Technological Characteristics

Diode laser system; wavelengths 810, 940, 980 nm; max power ≤ 100 W; pulse duration ≤ 2500 msec; repetition rate ≤ 200 Hz; fluence ≤ 120 J/cm2; spot size 0.6mm to 7.7 cm2; CW and pulsed output modes; fiber optic delivery with handpiece; LCD touchscreen interface; 230 VAC power; cooling system included.

Indications for Use

Indicated for patients requiring soft tissue surgery (incision, excision, ablation, coagulation, hemostasis) across dermatology, plastic surgery, vascular surgery, and podiatry. Specific uses include: vascular/pigmented lesion treatment, hair removal (skin types I-V), permanent hair reduction, endovenous occlusion of the greater saphenous vein, laser-assisted lipolysis, and temporary relief of minor muscle/joint pain/stiffness/spasm via elevated tissue temperature.

Regulatory Classification

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.

Predicate Devices

Alma Lasers Modified Diode Laser Module (K112031)
LAMBDA S.p.A. Doctor Diode Laser Family (K102036)
Quanta System QUANTA Diode Laser Family (K100558)
CAO Group Pilot Diode Laser (K100143)
Lumenis LightSheer Duet (K053628)

Related Devices

K213350 — mJOULE System and Accessories · Sciton, Inc · Apr 15, 2022
K101916 — JOULE MULTI-PLATFORM SYSTEM · Sciton, Inc · Mar 18, 2011
K213761 — Joule diVa System · Sciton, Inc · Jul 19, 2022
K090297 — BLUESHINE GOLD SERIES · Blueshine Srl · Apr 14, 2009
K960032 — COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS · Coherent Medical Group · Apr 1, 1996

Submission Summary (Full Text)

{0}------------------------------------------------ # 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. | {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. 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 {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 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 . {4}------------------------------------------------ | 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. | : . . {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) OR (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 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. 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) OR 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 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. 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