(132 days)
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
| 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, |
The provided text is a Summary of Safety and Effectiveness Information for the Reliant Technologies, Inc. Unica 315M R/G CO2 Laser System, submitted for 510(k) premarket notification. This type of document establishes substantial equivalence to already legally marketed devices, rather than conducting a de novo study to establish new acceptance criteria and prove performance against them.
Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets them, sample sizes, ground truth establishment, expert adjudication, or MRMC studies.
Instead, the document focuses on:
- Device Description: Physical and operational characteristics of the Unica 315M R/G CO2 Laser System.
- Intended Use: Broad application in general surgical procedures for soft tissue manipulation.
- Comparison to Predicate Devices: A detailed table comparing the Unica 315M R/G CO2 Laser System's specifications and indications to three legally marketed predicate CO2 laser systems (Luxar - LX-20SP, Coherent System 451, Sharplan 1020).
- Substantial Equivalence Argument: The core of the 510(k) submission, asserting that the Unica 315M R/G is as safe and effective as the predicate devices based on shared technological characteristics and intended use.
In summary, this document is a regulatory submission for premarket clearance based on substantial equivalence, not a clinical study report proving performance against defined acceptance criteria.
Therefore, I cannot provide the requested table and study details because the information is not present in 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.