(252 days)
Not Found
No
The summary describes a multi-wavelength laser/light system with various handpieces and delivery systems. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies for analysis, treatment planning, or control. The description focuses on the physical components and the different wavelengths and their intended uses.
Yes
The device is indicated for the treatment of various medical conditions, including vascular lesions, benign pigmented lesions, wrinkles, acne vulgaris, and varicose veins, which are therapeutic uses.
No
This device is a therapeutic and cosmetic laser system designed for various treatments like hair reduction, vascular lesion treatment, skin resurfacing, and soft tissue procedures, not for diagnosing medical conditions.
No
The device description explicitly states it is a "modular, multi-wavelength laser/light system" consisting of a "control console which houses the power supply, cooling system, fiber optic delivery system and/or articulated arm delivery system with handpiece and/or scanner." This clearly indicates the presence of significant hardware components beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses described for the various wavelengths of the JOULE Multi-Platform System are all related to treating conditions directly on or within the human body. These include hair reduction, treatment of vascular and pigmented lesions, wrinkle treatment, tattoo removal, soft tissue procedures (incision, excision, ablation, vaporization, coagulation, hemostasis), laser-assisted lipolysis, treatment of venous reflux, skin resurfacing, and treatment of acne.
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in the examination of specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnostic, monitoring, or compatibility purposes.
- Device Description: The device description focuses on the delivery of thermal energy to a treatment site on the body using laser/light systems, handpieces, and scanners. There is no mention of analyzing biological specimens.
The device described is a therapeutic laser/light system used for various medical and aesthetic procedures performed directly on patients.
N/A
Intended Use / Indications for 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 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 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).
Product codes (comma separated list FDA assigned to the subject device)
GEX, ONG, ORK, ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Soft tissue, vascular lesions, benign pigmented lesions, hair follicles, facial skin, lipolysis treatment sites, saphenous veins (great and small), superficial veins in lower extremity, skin, epidermis.
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.
K081352, K081324, K072868, K070388, K060033, K023881, K083899, K072564, K050382, K083613, K082230, K082225, K101506, K090195, K070284, K100270, K042165, K042630
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
§ 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.
0
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 Marketed | |
| Predicate Device: | 755 nm Laser System |
| K081352: Profile Multi-Platform System | |
| Q-Switched 755 nm Alex | |
| K081324: Candela Family of Q-Switched Alexandrite | |
| K072868: Cynosure Accolade II Laser | |
| 1064 nm Laser System | |
| K070388: Profile Multi-Platform System | |
| K060033: Profile Multi-Platform System | |
| K023881: Profile 1064 Laser System | |
| Q-Switched 1064/532 nm Nd:YAG | |
| K083899: Hoya ConBio RevLite Q-Switched Nd:YAG Laser System | |
| K072564: Alma Harmony XL Multi-Platform Q-Switched Nd:YAG | |
| K050382: Cynosure Affinity QS Q-Switched Nd:YAG Laser System | |
| 1319 nm Laser System | |
| K081352: Sciton Profile Multi-Platform System | |
| K070388: Sciton Profile Multi-Platform System | |
| K060033: Sciton Profile Multi-Platform System | |
| 1470 nm Laser System | |
| K083613: Quanta System Polysurge Diode Laser Family | |
| K082230: Xintec Vectra Family of Laser Systems and Accessories | |
| K082225: Biolitec Ceralas D 1470 nm Diode Laser | |
| 1470 nm Laser System (Fractional) | |
| K101506: Palomar Lux 1440 | |
| K090195: Palomar Lux1540 | |
| K070284: Reliant Technologies Fraxel SR1500 Laser System | |
| 1550 nm Laser System (Fractional) | |
| K090195: Palomar Lux1540 | |
| K070284: Reliant Technologies Fraxel SR1500 Laser System | |
| 2940 nm Laser System (Fractional) | |
| K081352: Sciton Profile Multi-Platform System | |
| K070388: Profile Multi-Platform System | |
| K060033: Profile Multi-Platform System | |
| K100270: Palomar LUX2940 | |
| BBL System | |
| K070388: Sciton Profile Multi-Platform System | |
| K060033: Sciton Profile Multi-Platform System | |
| K042165: Cutera Titan | |
| K042630: RevLight Skin Care System |
·
1
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
2
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.
4
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.
5
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
6
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
7
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.
1
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.
| 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
8
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 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:
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.
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)
OR
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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)
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);
| Prescription Use
| (Per 21CFR801) | X | OR |
|---|---|---|
| ------------------------------------ | --- | ---- |
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;
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).
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)