(42 days)
K.970757, K972368
No
The description focuses on the laser technology, power supply, cooling system, optical delivery, and a microprocessor-based controller for parameter selection. There is no mention of AI, ML, image processing, or any features that would suggest the use of such technologies.
Yes
The device description states, "The combined 'theraputic' and aiming beams are guided down an articulated arm delivery system to a focusing handpiece."
No
The device is described as a surgical laser system used for cutting, ablation, vaporization, coagulation of soft tissue, and skin resurfacing. Its function is to perform medical procedures, not to diagnose conditions.
No
The device description clearly outlines multiple hardware components including a laser rod, power supply, cooling system, and optical delivery system. While it mentions a microprocessor-based controller, this is part of a larger hardware system, not a standalone software device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting, ablation, vaporization, coagulation of soft tissue, and for skin resurfacing." These are all procedures performed directly on the patient's body.
- Device Description: The description details a laser system that delivers energy to the patient's tissue.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical laser used for therapeutic purposes directly on the patient.
N/A
Intended Use / Indications for Use
The Fotona SkinPlus Er. YAG surgical laser system is indicated for the cutting, ablation, vaporization, coagulation of soft tissue, and for skin resurfacing.
Product codes
GEX
Device Description
The Totona SkinPlus system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er.YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handoiece. The laser is used in non-contract mode. The System is capable of emitting up to 2.0 J of pulsed light at 2,94 um. This light has a pulsewidth which varies in the range 100 - 500 us. The laser is intended to be used for curting, ablating, vaporizing, coagulating of soft tissue, and skin resurfacing. The SkinPlus system is designed with 5 major sub-systems: a) A high voltage power supply which converts and rectifies the a.c. mains current to provide regulated power for the flashlamp simmer current and main tringgering pulse. b) A cooling system consisting of an internal water flow circuit together with water-to-air heat exchanger. c) An Er: Y AG laser rod, capable of generating 2.0 J optical pulses at a frequency up to 15 liz. d) An optical delivery system, interfacing the energy from the laser to the patient via an articulated arm and focusing handpiece. e) The microproccssor based controller which regulates the functions of the laser and allows parameter selection by the user.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K.970757, K972368
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K980560 MAR 2 7 1998
Appendix E Summary of Safety and Effectiveness Data :
General Information and Description
The Totona SkinPlus system is based on Er: YAG laser technology. Within the system, an optical cavity contains the Er.YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapuetic and aiming beams are guided down an articulated arm delivery system to a focusing handoiece. The laser is used in non-contract mode.
The System is capable of emitting up to 2.0 J of pulsed light at 2,94 um. This light has a pulsewidth which varies in the range 100 - 500 us. The laser is intended to be used for curting, ablating, vaporizing, coagulating of soft tissue, and skin resurfacing,