(15 days)
Indications for Use for Fitzpatrick skin types (I to VI)
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
- The treatment of moderate inflammatory acne vulgaris
- The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions including warts, scars, and striae.
- The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or 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)
- Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
The Accela is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accela emits light at 400nm to 1200nm via a 50mm x 50mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface, while cold air integrated through the handpiece, is provided to cool the epidermis.
This document is a 510(k) summary for the Accela System, an Intense Pulsed Light (IPL) device. It asserts substantial equivalence to predicate devices and describes the system's technical characteristics and indications for use. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes, expert ground truth, or adjudication methods for clinical studies.
The provided text focuses on:
- Device identification: Accela System, IPL, Class II device.
- Applicant and contact information.
- Predicate devices: Chromogenex (K053324), Sciton (K032460), Lumenis (K020839).
- System description: Xenon flash lamp, 400nm-1200nm light, 50mm x 50mm treatment area, 0.5Hz repetition rate, integrated cold air cooling.
- Performance Standards: Compliance with European Medical Directive 93/42/EEC and voluntary standard UL60601-1:1996 for the U.S. market.
- Indications for use:
- Permanent hair reduction (Fitzpatrick skin types I-VI)
- Moderate inflammatory acne vulgaris
- Benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides)
- Cutaneous lesions (warts, scars, striae)
- Benign cutaneous vascular lesions (port wine stains, hemangiomas, telangiectasias, rosacea erythema, angiomas, spider angiomas, poikiloderma of civatte, leg veins, venous malformations)
- Integrated thermal cooling benefits: reduce pain/discomfort, minimize thermal injury, allow higher fluences, reduce side effects during light/laser treatment.
- Substantial equivalence conclusion: Based on similarities to predicate devices in output spectrum, pulse characteristics, treatment parameters, despite differences in light delivery method and skin cooling method (convective cold air vs. conductive gel/contact cooling).
- Side Effects: Excessively red patches, blistering, which usually heal without scarring if managed appropriately.
- FDA Clearance Letter: Confirms the 510(k) clearance (K081578).
Given the absence of the requested data in the provided text, I must state that the document does not provide the information necessary to fulfill your request for acceptance criteria and the study details. A 510(k) summary typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, often relying on comparisons of technological characteristics, performance data (often non-clinical), and indications for use, rather than presenting detailed clinical study results with specific performance metrics and acceptance criteria as a separate "study."
To obtain the requested information, you would typically need to consult the full 510(k) submission or any accompanying clinical studies referenced or provided by the manufacturer to the FDA.
§ 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.