(132 days)
Not Found
No
The device description focuses on the physical and technical specifications of a CO2 laser system for surgical procedures. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes
The device is indicated for use in surgical procedures to vaporize, incise, excise, ablate, or photocoagulate soft tissue, which are all therapeutic actions.
No
The device is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue, which describes a treatment function rather than a diagnostic one.
No
The device description clearly outlines numerous hardware components including weight, dimensions, laser sources, beam delivery arm, battery, cooling system, and electrical requirements. This is a physical laser system, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures." This describes a device used on the patient's body during surgery, not a device used to test samples from the body (in vitro).
- Device Description: The description details a laser system with an articulated arm for delivering a laser beam. This is consistent with a surgical tool, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnosis, monitoring, or screening. This device's function is to directly interact with tissue during surgery.
N/A
Intended Use / Indications for Use
The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures
Product codes (comma separated list FDA assigned to the subject device)
79-GEX
Device Description
| Weight: | 33 lb. (15 kg.) |
|---|---|
| Dimensions: | Length: 19.6 in. (49 cm.) Height (folded arm): 7.5 in. (18 cm.) Width: 6.4 in. (16 cm.) |
| Main Laser Source: | CO2 laser, sealed wave guide tube TEM00. |
| Treatment Beam Wavelength: | 10,600 nm CO2 laser |
| Aiming Beam Wavelength: | 532 nm KTP or 635 nm GaAlAs-laser - max. output 5 milliwatt. |
| Modes of Operation*: | Superpulse/Pulse/Continuous Single or Repeat pulse trains |
| Beam Delivery: | 4 joint articulated arm that can be partially folded into the laser. |
| Battery backup: | Equipped with backup battery for 1 to 5 hours of operation depending on output power etc. |
| Battery charge cycle: | Full charge is achieved in 5 hours |
| Cooling system: | Internal cooling to instrument case. Overheat protection circuit. |
| Electric requirements: | Single phase 220-230V 50 Hz, |
§ 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
SEP 20 2 3
in
Summary of Safety and Effectiveness Information Reliant Technologies, Inc. Unica 315M R/G CO2 Laser System Safe Medical Devices Act of 1990, 21CFR807.92
-
- Device Name(s)
| Trade Name: | Unica 315M R/G CO₂ Surgical Laser System |
|---|---|
| Common Name: | CO₂ Surgical Laser |
| Classification Name: | Instrument, Surgical, Powered, Laser |
| § 878.4810 Laser surgical instrument for use in general and plastic surgery and dermatology. Classification: Class II. | |
| Classification Panel: | General & Plastic Surgery Devices Panel |
| Product Code(s): | 79-GEX |
2. Establishment Name & Registration Number:
Reliant Technologies, Inc. Name:
Number: 2950711
3. Special Controls:
This device complies with CDRH radiation control regulations as outlined in:
21 CFR §1040, Performance Standards for Light Emitting Products
21 CFR §1010, Performance Standards for Electronic Products, general.
4. Labeling:
The Unica 315M R/G is indicated for use as a surgical instrument to vaporize, incise, excise, ablate or photocoagulate soft tissue in general surgical procedures.
Required laser warning and caution statements are displayed as required for surgical laser devices.
1
5. Device Description:
| Weight: | 33 lb. (15 kg.) |
|---|---|
| Dimensions: | Length: |
| 19.6 in. (49 cm.) | |
| Height (folded arm): | |
| 7.5 in. (18 cm.) | |
| Width: | |
| 6.4 in. (16 cm.) | |
| Main Laser Source: | CO2 laser, sealed wave guide tube TEM00. |
| Treatment Beam | |
| Wavelength: | 10,600 nm CO2 laser |
| Aiming Beam | |
| Wavelength: | 532 nm KTP or 635 nm GaAlAs-laser - max. output 5 milliwatt. |
| Modes of Operation*: | Superpulse/Pulse/Continuous |
| Single or Repeat pulse trains | |
| Beam Delivery: | 4 joint articulated arm that can be partially folded into the laser. |
| Battery backup: | Equipped with backup battery for 1 to 5 hours of operation |
| depending on output power etc. | |
| Battery charge cycle: | Full charge is achieved in 5 hours |
| Cooling system: | Internal cooling to instrument case. Overheat protection circuit. |
| Electric requirements: | Single phase 220-230V 50 Hz, |