# K062321: Smartlipo ND:Yag Laser

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc.
- Decided: Oct 31, 2006 after 83 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.
182 later devices descend from it; 8 cite it directly.
0 of 183 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Laserscope Lyra Series Nd:YAG Laser system: named in the summary without a submission number

## Most influential descendants
- K072779: Ceralas D 980NM Diode Laser, Models D15 and D25 (2008), 153 descendants of its own
- K070388: Profile Multi-Platform System (2007), 129 descendants of its own
- K072751: Cooltouch Models NS 160 and LC215 Coolipo (2008), 125 descendants of its own
- K081352: Profile Multi-Platform System (2008), 112 descendants of its own
- K101916: Joule Multi-Platform System (2011), 111 descendants of its own

## Indications for use
The SmartLipo Laser is intended for the surgical incision, excision, vaporization, ablation, and coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, mucous membrane, lymph vessels and nodes, organs and glands. The SmartLipo is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K062321
Methodology: https://510kreport.com/methodology