(60 days)
The 500 – 1200nm intense pulsed light wavelengths are indicated for:
- The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
- The treatment of cutaneous lesions, including warts, scars and striae
The 560 – 1200nm intense pulsed light wavelengths are indicated for: - 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
The 600 - 1200nm intense pulsed light wavelengths are indicated for: - The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - 1200nm intense pulsed light wavelengths are indicated for: - The treatment of moderate inflammatory acne vulgaris.
The Fusion System consists of:
The main console unit that incorporates the touch-screen control panel, power supply module, cooling system, switching module and isolation transformer
Variety of handpieces
Footswitch
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fusion System, extracting the requested information:
Assessment: The provided document is a 510(k) summary for a medical device (Fusion System), which is primarily focused on demonstrating substantial equivalence to a predicate device. While it lists intended uses, it explicitly states "None" for "Performance Data: Results of Clinical Study:", and "None" for "Conclusion:" regarding performance data specific to the Fusion System itself. Therefore, many of the requested details about acceptance criteria, device performance, and study specifics cannot be found in this document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | Not specified |
| No performance metrics or thresholds are provided in the document. | The document explicitly states "None" for "Results of Clinical Study" and "None" for "Conclusion" regarding performance data. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document states "None" under "Results of Clinical Study".
- Data Provenance: Not specified. No clinical study data is reported.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable, as no external test set or ground truth establishment is reported for performance evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Not applicable, as no external test set or adjudication process is reported.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. The document states "None" for "Results of Clinical Study".
- Effect Size: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone study was not done or reported. The device is a physical IPL system, not an algorithm. The document explicitly states "None" for "Results of Clinical Study".
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable, as no ground truth was established or used for performance evaluation within this document.
8. The sample size for the training set
- Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable, as this device is an Intense Pulsed Light (IPL) system, not an AI algorithm. Therefore, there is no "training set" or ground truth establishment in this context.
§ 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.