(108 days)
The Lovely System models (Aria and Harmony) are intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of plastic surgery and dermatology as follows:
Lovely I (Aria) & Lovely II (Harmony) Models:
The Advanced Fluorescence Technology (AFT) with 420-950 nm wavelengths is indicated for:
- 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, rosacea, erytherna of rosacea, angiomas and spider angiomas, poikiloderma of Civatte, leg veins and voenous, malformations.
- The removal of unwanted hair and to effect stable long-term or permanent hair reduction. ●
Lovely II (Harmony) Model:
The Nd: YAG lasers (1064nm) are indicated for:
- The removal of black, blue or green tattoos. .
- Coagulation and hemostasis of vascular lesions and soft tissue, including treatment and clearance of superficial and deep telangiectasias) and reticular veing (0.1-4.0 mm diameter) of the leg.
- The non-ablative treatment of facial wrinkles. .
Lovely II (Harmony) Model:
- The UVB Light source (300-380nm) is indicated for:
- The treatment of leukoderma, including vitiligo (acquired leukoderma). .
- The treatment of psoriasis, atopic dermatitis (eczema), and seborrheic dermatitis.
The Lovely System models are also indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Lovely is a platform for AFT, UVB and Nd:YAG Laser Technology for various Aesthetic and Cosmetic applications. The Lovely has an option to operate seven different handpieces that emits light at 300nm to 1064nm for the following applications:
- Hair removal 트
- Skin Rejuvenation 트
- I Vascular and Pigmented lesion
- 트 Moderate Acne
- 트 Deep leg veins
- . Tattoo removal
- 트 Psoriasis and vitiligo
The system includes:
- A light/laser system console (including software and control 트 electronics) that controls timing and dosing parameters. The console includes a water-cooling system used to remove heat from the power supply and the optical bench.
- A control and display panel including LCD and soft-keys. 트
- Seven optional handpiece(s) that includes the light source, 트 electronics and pipes of the water cooling system.
This document is a 510(k) summary for the "Lovely System" (Models: Lovely I (Aria) & Lovely II (Harmony)), a laser and light-based system for aesthetic and cosmetic applications. Unfortunately, the provided text does not contain acceptance criteria or a detailed study proving the device meets those criteria.
Instead, the document primarily focuses on establishing substantial equivalence to predicate devices, which is the primary requirement for a 510(k) submission. While it mentions "Safety and performance testing" as evidence of equivalence, it does not describe the specific tests performed, the acceptance criteria for those tests, or the results.
Therefore, I cannot provide the requested information in the format specified because the detailed study information is not present in the provided text.
However, I can extract information related to what would typically be considered for such a study, based on the indications for use and the nature of the device:
Indications for Use (which would drive the types of studies performed):
- Treatment of moderate inflammatory acne vulgaris.
- Treatment of benign pigmented epidermal lesions (dyschromia, hyperpigmentation, melasma, ephelides/freckles).
- Treatment of cutaneous lesions (warts, scars, striae).
- Treatment of benign cutaneous vascular lesions (port wine stains, hemangiomas, facial/truncal/leg telangiectasias, rosacea, erythema of rosacea, angiomas, spider angiomas, poikiloderma of Civatte, leg veins, venous malformations).
- Removal of unwanted hair and stable long-term or permanent hair reduction.
- Removal of black, blue, or green tattoos.
- Coagulation and hemostasis of vascular lesions and soft tissue, including superficial and deep telangiectasias and reticular veins.
- Non-ablative treatment of facial wrinkles.
- Treatment of leukoderma (including vitiligo).
- Treatment of psoriasis, atopic dermatitis, and seborrheic dermatitis.
- Intended for use on all skin types (Fitzpatrick I-VI), including tanned skin.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts and their qualifications for ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect size.
- Standalone (algorithm-only) performance results.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document only broadly states: "- Safety and performance testing." was conducted without providing any specifics. For a complete answer to your request, the actual study reports would be needed.
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
(a)
Identification. An ultraviolet lamp for dermatologic disorders is a device (including a fixture) intended to provide ultraviolet radiation of the body to photoactivate a drug in the treatment of a dermatologic disorder if the labeling of the drug intended for use with the device bears adequate directions for the device's use with that drug.(b)
Classification. Class II.