(39 days)
Indications for use for Fitzpatrick skin types (I to V).
The Chromolite™ EP System is intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostatis of soft tissue in the medical specialities of plastic surgery and dermatology as follows:-
Indications for use for Fitzpatrick skin types (I to V).
- . The treatment of moderate inflammatory acne vulgaris
- The treatment of benign pigmented epidermal lesions including dyschromia, hyper-. pigmentation, melasma, ephelides (freckles)
- . The treatment of cutaneous lesions including warts,scars, and striae.
- . The treatment of benign cutaneous vascular lesioins, including port wine stains, hemamangiomas, facial, truncal, and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
- . The removal of unwanted hair and to effect stable long-term or permanent hair reduction.
1 = Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
The Chromolite™ EP System is an Intense Pulsed Light-based medical device utilising xenon flashlamp technology to illuminate, to offer light based therapies as listed in the indications for use. The Chromolite" " EP System emits light at 390nm to 1200nm via a 50mm x 15mm waveguide at a repetition rate of up to 0.5Hz.
The provided text is a 510(k) summary for the Chromolite™ EP System, an Intense Pulsed Light (IPL) device. It describes the device, its intended use, and compares it to a predicate device. However, it does not contain any information about acceptance criteria, a study proving device performance against such criteria, sample sizes, expert involvement, ground truth establishment, or specific performance metrics.
The document states that the Chromolite™ EP System is a hardware and software modification of a previously cleared device (Chomolite™ System) and that both have the same intended use and operating principle. The FDA's letter confirms substantial equivalence to a legally marketed predicate device. This implies that the device's safety and effectiveness are established by demonstrating it is as safe and effective as a device already on the market, rather than through a new, independent performance study meeting specific acceptance criteria that would typically be described for a novel device or a device claiming a new indication.
Therefore, I cannot fulfill your request for:
- Table of acceptance criteria and reported device performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device.
- Sample sizes, data provenance: Not mentioned.
- Number of experts and qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned and likely not applicable for a substantial equivalence claim based on modifications to an existing IPL device.
- Standalone performance: Not mentioned. The device's performance is implicitly linked to the predicate device it is substantially equivalent to.
- Type of ground truth: Not mentioned.
- Training set sample size: Not mentioned.
- How ground truth for training set was established: Not mentioned.
The 510(k) summary provided is focused on regulatory clearance through substantial equivalence, not on detailing a performance study with specific acceptance criteria and results.
§ 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.