# K971821: Unica 315 M CO2 Surgical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Sep 25, 1997 after 132 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K860087 (1986). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K953074: Modified Luxar LX-20 Family CO2 Laser System, Luxar Corp. (1995) Summary page 4.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 4.
- K860087: Sharplan Model 1020 CO2 Surgical Laser System, Sharplan Lasers, Inc. (1986) Summary page 4.

## 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

Source page: https://510kreport.com/device/K971821
Methodology: https://510kreport.com/methodology