(91 days)
VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lessions, hair removal and permanent harr reduction. 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. SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions. PRISMA LASER handpiece: Indicated for removal of dark tattoos and treatment of benign pigmented lesions. RUBER, LILAC Pulsed Light handpieces: Permanent hair reduction, photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions. Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table: 500-1200nm: Benign Vascular lesions Skin Types I, II; Blood vessels Skin Types I, II. 520-1200nm: Benign Vascular lesions SkinType III; Blood Type III; Benign Pigmented lesions Skin Types I, II. 550-1200nm: Hair reduction Skin Types I, II; Benign Pigmented lesions Skin Type Ill. 600-1200nm: Hair reduction Skin Type Ill. 650-1200nm: Hair reduction Skin Type IV; Benign Pigmented lesions Skin Type IV. LAZUR Pulsed Light handpiece: The handpiece (with and without contact-cooling) is indicated for: -The treatment of moderate inflammatory acne vulgaris. -The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). -The treatment of benign cutaneous lesions including warts, scars and striae. -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. - Use on all skin types (Fitzpatrick I-VI). VIRIDIS Pulsed Light handpiece: Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial andleg veins), and the treatment of benign pigmented lesions.
The DEKA LUXEA is a versatile medical platform that can be equipped with various types of laser and pulsed light handpieces. Thanks to its universal connector it is possible to quickly insert and deactivate the various handpieces to cover a wide spectrum of application. The available handpieces are - VIVID: 808±10 nm Laser - SPARKS: 1064nm Laser - PRISMA: 1064nm O-Switched laser - VIRIDIS: Pulsed Light handpiece 15mmx13mm with integrated 500-1200 nm filter - LILAC: Pulsed Light handpiece 48mmx13mm with interchangeable filters - RUBER: Pulsed Light handpiece 48mmx17mm with integrated 550mm filter - LAZUR: Pulsed Light handpiece 48mmx13mm with integrated 420-950 nm filter Emission activation is either by footswitch or fingerswitch. Electrical specifications are 115-240V~, 50-60Hz, 2300VA max.
The provided text is a 510(k) Pre-Market Notification from the FDA regarding the DEKA LUXEA device. This document focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific performance acceptance criteria for a new clinical claim.
Therefore, the document does not contain the information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance: This document explicitly states "Clinical Performance Data: None." The performance metrics provided (fluence, spot size, pulse duration, repetition rate) are technical specifications for comparison to predicate devices, not performance against clinical acceptance criteria.
- Sample size used for the test set and the data provenance: No clinical test set data is presented.
- Number of experts used to establish the ground truth... and their qualifications: No ground truth establishment is described as there's no clinical data.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Explanation of the Document's Purpose:
This 510(k) submission primarily relies on the "substantial equivalence" pathway for regulatory clearance. This means the manufacturer is asserting that their new device is as safe and effective as a legally marketed device (predicate device) that was on the market before May 28, 1976, or has been reclassified.
To establish substantial equivalence, manufacturers typically compare their new device to predicate devices in terms of:
- Indications for Use: The DEKA LUXEA handpieces have indications for use that are very similar to their respective predicate devices.
- Technological Characteristics: The document provides detailed comparisons of technical specifications like laser wavelength, fluence, spot sizes, pulse duration, and pulse repetition rate for each handpiece against its chosen predicate. The core argument is that these characteristics are either identical or sufficiently similar that the device is as safe and effective as the predicate.
- Non-Clinical Performance Data: The document explicitly mentions conformance with safety and electromagnetic compatibility (EMC) standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-22, IEC 60825-1, IEC 60601-2-57). This demonstrates electrical safety and performance within established engineering norms, not clinical performance for specific outcomes.
- Clinical Performance Data: The document explicitly states "None." This is common for 510(k) submissions where substantial equivalence can be established through non-clinical means and comparison of technological characteristics.
In summary, the provided FDA document is a regulatory submission demonstrating substantial equivalence, not a clinical study proving device performance against specific acceptance criteria for a new clinical claim.
§ 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.