(226 days)
The Cosmelight Intense Pulsed Light System (and its accessories) are indicated for use in surgical, aesthetic and cosmetic applications (requiring photothermolysis, photocoagulation and dermatology) in the treatment of acne, varlous benign pigmente lestons and hair removal as follow:
- Intense Pulse Light Energy Wavelengths from 400 - 950 nm are indicated for the reatment of: inflammatory acne.
- Intense Pulse Light Energy Wavelengths from 560 - 1200 nm are indicated for the treatment of: benign pigmented (epidermal and coetaneous) lesions including warts, cars and striae. For the treatment of benign (cutaneous) vascular lessons including ort wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider anglormas, poikiloderma of civatte, leg veins, facial veins and venous malformations.
- Intense Pulse Light Energy Wavelengths from 700 - 1200 nm are indicated for the treatment of: unwanted hair (i.e., hair removal).
The Cosmelight Intense Pulsed Light System is comprised of the following main components:
• A control console unit.
• A control and color display panel.
• Two removable handpieces with an integrated trigger switch and a Cooling System (a cooling device integrated into the handpieces. Quick Cool Handle ( QCH )
• Power supply.
The provided text is a 510(k) summary for the Cosmelight Intense Pulsed Light system. It declares the device to be substantially equivalent to legally marketed predicate devices, rather than presenting a study proving it meets specific acceptance criteria through novel performance data. Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to such a study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria with corresponding performance metrics from a specific study of the Cosmelight device. Instead, it relies on the concept of substantial equivalence to predicate devices. The "Performance Data" section states: "The differences in specifications of the Cosmelight system and the Predicate devices do not result in different performance or raise new questions of safety and efficacy." This implies that the performance of the Cosmelight is considered to be on par with the predicate devices, which have already been deemed safe and effective.
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe a clinical study with a test set of data for the Cosmelight device itself. Its submission is based on substantial equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No new ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable. There is no described test set or adjudication process for the Cosmelight device's performance.
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:
Not applicable. This device is an Intense Pulsed Light system, not an AI-powered diagnostic or assistive technology for human readers. Such a study would not be relevant in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a medical device for treatment, not a standalone algorithm.
7. The type of ground truth used:
Not applicable for the Cosmelight device's submission. The "ground truth" in this context is implicitly established by the prior regulatory clearance and market history of the predicate devices.
8. The sample size for the training set:
Not applicable. The Cosmelight system is not an AI/ML algorithm that requires a training set in the conventional sense. Its development would involve engineering and device testing, not a dataset for model training.
9. How the ground truth for the training set was established:
Not applicable. No training set is described for this device.
Summary of what can be gleaned from the document regarding "proof of meeting acceptance criteria":
The document's core argument for device acceptance is substantial equivalence to four legally marketed predicate devices:
- Lumenis Inc IPL Quantum, K020839
- Palomar Inc. EsteLux, K020453
- McCue Plc. McCue Energist ULTRA, K040659
- DDD A/S, Ellipse I2 PL, K060516
The "Performance Data" section explicitly states that the differences in specifications between the Cosmelight system and these predicate devices "do not result in different performance or raise new questions of safety and efficacy." This implies that the Cosmelight's performance, safety, and efficacy are considered to be equivalent to those predicate devices, which have already "met acceptance criteria" in their respective 510(k) clearances. The FDA's letter (K061720) confirms this by stating, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices."
§ 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.