# K992814: Cynosure Accolade Laser

- Pathway: 510(k) (Special)
- Applicant: Cynosure, Inc.
- Decided: Sep 15, 1999 after 26 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
No predicates in its family tree.
88 later devices descend from it; 1 cites it directly.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K972214: Roche Serum Control Normal (Human), Roche Serum Control Pathological (Human), Roche Diagnostic Systems, Inc. (1997). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K121346: Picosure Workstation (2012), 87 descendants of its own
- K142372: Pico Way Laser System (2014), 70 descendants of its own
- K150326: PicoWay Laser System (2015), 68 descendants of its own
- K133364: Picosure Workstation (2014), 51 descendants of its own
- K140719: Picosure Workstation (2014), 50 descendants of its own

## Indications for use
The Cynosure Accolade Laser is indicated for tattoo and benign cutaneous pigmented lesions removal.

Source page: https://510kreport.com/device/K992814
Methodology: https://510kreport.com/methodology