(83 days)
The Spectra VRMIII Laser System is indicated for the incision, excision, ablation, vaporization of soft tissues for general dermatology, dermatologic and general surgical procedures for coagulation and hemostasis.
- 532nm Wavelength (nominal delivered energy of 585 nm and 650 nm with optional dye handpieces):
- Tattoo removal: light ink (red, tan, purple, orange, sky blue, green)
- Removal of Epidermal Pigmented Lesions
- Removal of Minor Vascular Lesions including but not limited to telangiectasias
- Treatment of Lentigines
- Treatment of Café-Au-Lait
- Treatment of Seborrheic Keratoses
- Treatment of Post Inflammatory Hyper-Pigmentation
- Treatment of Becker's Nevi, Freckles and Nevi Spilus
- 1064nm Wavelength:
- Tattoo removal: dark ink (black, blue and brown)
- Removal of Nevus of Ota
- Removal or lightening of unwanted hair with or without adjuvant preparation.
- Treatment of Common Nevi
- Skin resurfacing procedures for the treatment of acne scars and wrinkles
The Spectra VRMIII Laser System produces a pulsed beam of coherent near infrared (1064 nm) and visible (532nm) light. This beam is directed to the treatment zone by means of an articulated arm coupled to a handpiece. In addition, two dye handpieces are available that convert the 532 nm wavelength to 585 nm and 650 nm. When the beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapid, highly localized temperature increase to the target chromospheres such as melanin and tattoo particles. This increases localized temperature of the chromospheres. The instantaneous temperature increase causes fragmentation of the chromospheres to smaller particles. By directing the beam onto specific tissue locations, using different handpieces, and controlling the treatment fluence, the intensity of the temperature of the target can be varied. The physician can optimize the effect for different applications by controlling the energy of the laser pulse and the spot size of the treatment beam.
The provided text is a 510(k) Summary for the Lutronic Corporation Spectra VRMIII Laser System. It is a premarket notification for a medical device seeking substantial equivalence to legally marketed predicate devices. Crucially, this document explicitly states "Performance Data: None presented."
Therefore, based on the provided text, the device did not undergo a study to prove it meets acceptance criteria in the context of clinical performance or effectiveness. The 510(k) process often relies on demonstrating substantial equivalence to existing devices rather than new clinical trials for performance.
Given this, I cannot provide the requested information, but I can elaborate on why:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Performance Data: None presented." This means there are no reported acceptance criteria or reported device performance metrics in this submission.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. No test set was described as no performance data was presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Cannot be provided. No test set or ground truth establishment was described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. No test set or adjudication method was described.
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:
- Cannot be provided. No MRMC study or AI component is mentioned. This device is a laser system, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is a laser system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Cannot be provided. No performance data or ground truth establishment was described.
8. The sample size for the training set:
- Cannot be provided. No training set was described. This is a laser system, not a machine learning model.
9. How the ground truth for the training set was established:
- Cannot be provided. No training set or ground truth establishment was described.
In summary, the 510(k) summary explicitly states "Performance Data: None presented," indicating that the document primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing new clinical performance data from studies.
§ 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.