# K040617: Reliant Laser System II

- Pathway: 510(k) (Traditional)
- Applicant: Reliant Technologies, Inc.
- Decided: Jun 15, 2004 after 98 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: 8 generations back to K910422 (1992). 96 ancestors in all.
316 later devices descend from it; 5 cite it directly.
0 of 413 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031795: Reliant Laser System, Reliant Technologies, Inc. (2003) Summary page 1.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.
- K023734: Aramis II Dermatological Laser, Quantel Medical (2003) Summary page 1.
- K030846: Candela Smoothbeam Laser System, Candela Corp. (2003) Summary page 1.
- K033172: Candela Gentleyag Family of Laser Systems, Candela Corp. (2003) Summary page 1.
- K022060: Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device Accessories, Lumenis, Inc. (2002) Summary page 1.

## Most influential descendants
- K042319: Reliant Laser II System and Accessories (2005), 284 descendants of its own
- K061652: Palomar LUX1540 Handpiece (2007), 259 descendants of its own
- K060310: Fraxel II SR Laser System and Accessories (2006), 230 descendants of its own
- K062303: Fraxel II SR Laser System (2007), 226 descendants of its own
- K063038: Fraxel Iii SR Laser System and Accessories (2007), 195 descendants of its own

## Indications for use
The Reliant Technologies Laser System II is intended for: - Dermatological procedures requiring the coagulation of soft tissue; - Treatment of periorbital wrinkles; - Photocoagulation of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and dyschromia.

Source page: https://510kreport.com/device/K040617
Methodology: https://510kreport.com/methodology