(88 days)
1064 nm
The DermaV Laser System is indicated for stable long term or permanent hair reduction and for treatment of PFB (Pseudofolliculitis Barbae) on all skin types, Fitzpatrick I – VI, including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The 1064 nm laser is also indicated for coagulation and hemostasis of vasular lesions of vascular lesions such as but not limited to port wine stains, hemangiomna, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. The 1064 mm laser system is also indicated for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), café au lait macules, sebortheic keratoses, nevi, chloasma, verucae, skin tags, keratoses, (significant reduction in the intensity of black and/or blue- black tattoos) and plaques. The 1064 nm Laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles.
532 nm
For coagulation and hemostasis of vascular and cutaneous lesions in dermatology, including, but not limited to, the following general categories: vascular lesions [angiomas (port wine), telangiectasia (facial or extremities telangiectasias, venous anomalies, leg veins)]; benign pigmented lesions [nevi, lentigines, chloasma, café-au-lait, tattoos (red and green ink)]; verrucae; skin tags; keratoses; plaques; and cutaneous lesion treatment (hemostasis, color lightening, blanching, flattening, reduction of lesion size).
The DermaV laser system contains a Nd:YAG (Neodymium-doped Yttrium Aluminum Garnet) resonator which generates pulsed laser energy at the nominal wavelengths of 1064 mm and 532 nm using KTP. The outputs of each laser generator and the aiming beam (635 nm) are optically combined on the laser rail so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system for either the 532 nm or 1064 nm wavelength.
The control panel is equipped with an LCD touch screen so that users can easily adjust parameters for optimal settings. The software included provides all the function which is necessary to use the device.
The DermaV laser system is comprised of three main components: system main body, optical fiber with handpiece, and footswitch.
The DermaV laser system emits laser energy at 532 nm via a handpiece attached to an optical fiber. The DermaV laser system can be configured with an ICD (Intelligent Cooling Device) skin cooling device. The pulsed beam is directed to the treatment zone through a lenscoupled optical fiber attached to a handpiece. When the beam contacts human tissue, the energy of the beam is absorbed by the tissue, resulting in a very rapid and highly localized temperature increase in the target. The short but swift temperature increase causes selective heating and destroys of the target materials into smaller particles.
The DermaV Laser System did not have specific acceptance criteria for clinical performance explicitly stated in this document. The document states "Clinical performance testing was not needed for this submission; therefore, no clinical tests were submitted." This implies that regulatory clearance was sought based on substantial equivalence to predicate devices and non-clinical performance testing.
Therefore, the following information cannot be provided from the given document:
- A table of acceptance criteria and the reported device performance.
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size.
- Whether a standalone (algorithm only) performance was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Instead, the document details non-clinical performance testing, which serves as the "study that proves the device meets (non-clinical) acceptance criteria":
Non-clinical Performance Testing:
The DermaV Laser System underwent several non-clinical tests to demonstrate its safety and conformance with relevant standards. These tests effectively serve as the "acceptance criteria" for its non-clinical performance.
- Electrical Safety: The device was tested and found to be in conformance with IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
- Electromagnetic Compatibility (EMC): The device was found to be in conformance with IEC 60601-1-2 (Medical electrical equipment Part 1-2 General requirements for basic safety and essential performance- Collateral standard: Electromagnetic Disturbances-Requirements and tests).
- Laser Safety: The device was tested and found in conformance with IEC 60825-1 (Safety of laser products-Part 1: Equipment classification and requirements).
- Biocompatibility: The device was tested and found to be in conformance with:
- ISO 10993-1 ("Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process")
- ISO 10993-5 ("Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity")
- ISO 10993-10 ("Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization")
Comparison to Predicate Devices (Substantial Equivalence):
The primary method for establishing equivalence and, by extension, the acceptability of the device for its intended use, was through comparison with predicate devices. This comparison focused on:
- Intended Use: The DermaV Laser System's 1064 nm functions were compared to the Lutronic Corporation CLARITY II Laser System (K183566), and its 532 nm functions were compared to the Cutera Family of Coolglide Aesthetic Lasers (K153671). The document states that the proposed device and predicates have the "same intended use."
- Technological Characteristics: The document provides detailed tables (Table 1 and Table 2) comparing various technical characteristics such as:
- Manufacturer
- 510(k) Number
- Product Code
- Laser Wavelength
- Indications for Use
- Laser Type
- Beam Delivery
- Aiming Beam
- Pulse Energy
- Pulse Width
- Max Fluence (J/cm²)
- Pulse Rate
- CDRH Laser Class
- User Interface
- Spot Size
- Emission Control
- Integrated Cooling
The conclusion drawn from this comparison is that "Differences in the proposed device's technical features, such as software, biocompatibility, and laser output parameters, do not raise new types of questions regarding the device's safety and efficacy for its indications for use."
§ 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.