(160 days)
The GSD Intense Pulsed Light System (inclusive of the handpieces used to deliver pulsed-light energy) is indicated for use in surgical, asthetic and cosmetic applications in the treatment of acne , treatment of benign pigmented lesions, hair removal, treatment of vascular lesions as following:
- Intense Pulsed Light energy wavelengths from 500-1200nm are indicated for the treatment of pigmented lesions, hair removal, and treatment of vascular lesions.
- Intense Pulsed Light energy wavelengths from 400nm-1200nm are indicated for the treatment of acne.
- Intense Pulsed Light energy wavelengths from 750nm-1200nm are indicated for the treatment of benign pigmented lesions, hair removal, and treatment of vascular lesions.
The GSD Intense Pulsed Light System (GP666C4 and GP666C) is an intense pulsed light system which delivers intense pulsed light at a wavelength ranging from 400nm-1200nm. Intense Pulsed Light (IPL) systems work on the principles of selective photothermolysis. That is, causing thermal damage to target chromophores by using light of appropriate wavelength in pulses that exceeds the chromophores' thermal relaxation time but sparing normal skin by limiting the pulse width below the thermal relaxation time for skin.
This appears to be a 510(k) summary for the GSD Intense Pulsed Light System, which is a device for various dermatological treatments. The document states that the device is substantially equivalent to legally marketed predicate devices.
However, the provided text does not contain any information regarding specific acceptance criteria, study design, or performance metrics that would allow me to fill out the requested table and answer the detailed questions about a study proving the device meets acceptance criteria.
The 510(k) summary primarily focuses on:
- Device Description: What the device is and how it generally works (selective photothermolysis).
- Standards Compliance: Listing IEC 60601-1 and IEC 60601-1-2 as standards the device is designed, tested, and manufactured in accordance with. These are general safety and EMC standards, not performance criteria for clinical effectiveness.
- Substantial Equivalence Determination: Stating that the device is substantially equivalent to predicate devices.
- Intended Use/Indications for Use: Listing the medical conditions the device is intended to treat and the associated wavelength ranges.
Therefore, I cannot provide the requested information because the input text does not contain a study report or data on device performance against specific acceptance criteria.
To answer your questions, I would need a section detailing:
- Specific clinical performance endpoints (e.g., clearance rate for acne, hair reduction percentage, lesion fading percentage).
- Quantitative acceptance criteria for these endpoints (e.g., "90% hair reduction after X treatments").
- Results from a clinical study demonstrating achievement of these criteria.
- Details about the study design, sample size, data provenance, ground truth establishment, etc.
Since this information is absent, I must state that a direct response with the requested table and study details is not possible based on the provided text.
§ 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.