# K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quantel Medical
- Decided: Aug 16, 2002 after 88 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: 6 generations back to K963094 (1996). 42 ancestors in all.
No later device cites it as a predicate yet.
0 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981952: Combination ND:Yag and Frequency Doubled Solid State Green Laser, Instruments For Medicine and Diagnostics (1998) Summary page 1.
- K003202: Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II, Altus Medical (2001) Summary page 1.
- K003765: Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration), Laserscope (2001) Summary page 1.
- K010834: Lyra Series Surgical Laser System & Accessories, Laserscope (2001)
- K990903: Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration), Laserscope (1999) Summary page 1.
- K020463: Depilase Yag Lase Plus Laser System, Depilase Group, Ltd. (2002) Summary page 1.
- K941841: Smartscan, Laserscope (1994)
- K971024: Softscan, Sahar Technologies, Inc. (1997) Summary page 1.
- K980001: Jenascan, Jenoptik Laser, Optik, Systeme GmbH (1998) Summary page 1.
- K970757: Fotona Skinscan, Medical Laser Solutions (1997) Summary page 1.
- K020071: Viridis Derma Laser, Quantel Medical (2002)
- K951033: Andela Dynamic Cooling Device, Candela Laser Corp. (1996) Summary page 2.
- K972002: Cynosure Dermatology Laser Cooling Tip, Cynosure, Inc. (1997) Summary page 2.
- K984110: Laserscope Coolspot, Laserscope (1998) Summary page 2.
- K990417: Dermacool, Optomed Corp. (1999) Summary page 2.
- K963947: Epilaser Normal Mode Ruby Laser, Spectrum Medical Technologies, Inc. (1997) Summary page 2.
- K984601: Candela Gentlelase II Dermatological Laser, Candela Corp. (1999) Summary page 2.

## Cited in the summary but kept off the family tree
- K980865: Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071, 9076, 9081 and 9131, Phamatech (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
The General Surgery Indications for Use for the Athos laser are modified as follow: General Surgery: Soft tissue in general surgery applications, skin incisions, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors, lesions, tissue ablation, vessel coagulation, and treatment of leg veins. The Athoscan and Constans Cooling System are indicated for use with the Athos laser for indications for which the laser has been cleared. The Athoscan and Constans Cooling System are also labeled: “CAUTION: Federal law restricts the sale to or use by licensed professionals.”

Source page: https://510kreport.com/device/K021650
Methodology: https://510kreport.com/methodology