(252 days)
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).
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.
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.
§ 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.