510(k) · Cleared

Cleared

Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser

K021650510(k) TraditionalCleared Aug 16, 200288-day reviewClass II21 CFR 878.4810

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Quantel Medical · GEX Powered Laser Surgical Instrument

Cleared on Aug 16, 2002 as substantially equivalent to K981952 (Instruments For Medicine and Diagnostics, 1998) and 16 other predicates after an 88-day review. Its family tree reaches back 6 generations to 1996.

Decided: Aug 16, 2002
Review: 88 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 18

Its longest line of descent runs back 6 generations to K963094 (1996). 42 ancestors in all, the oldest K883541 (1988). No later device cites it as a predicate yet.

By dateBy generation

Root · 6 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
5 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
4 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
3 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
2 generations backK991798 Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000
1 generation backK020463 Depilase Yag Lase Plus Laser SystemDepilase Group, Ltd. · 2002
This deviceK021650 Athoscan for the Athos Laser Constans Cooling Hand Piece for the…Quantel Medical · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−6	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−5	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	1
−4	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−3	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−2	K991798	Acme Medical Aesthetic ND:Yag Laser	Altus Medical	2000	—
−1	K020463	Depilase Yag Lase Plus Laser System	Depilase Group, Ltd.	2002	—
0 (this device)	K021650	Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser	Quantel Medical	2002	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1988	1	0
1990	1	0
1994	2	0
1995	3	0
1996	5	0
1997	10	0
1998	5	0
1999	3	0
2000	2	0
2001	3	0
2002	1	0

FIG. 1 — Lineage of K021650, 1996–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GEX device

#1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (18)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.

Type	Number	Device	Applicant	Decided	Recalls
*	K981952	Combination ND:Yag and Frequency Doubled Solid State Green Laser Summary page 1 …e: dermatology (see: 21 CFR 878.4810). Product Code: GEX Panel: 79 Predicate devices: Leg Veins: The HGM VeirLase 6981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd:YAG o(003765; KO10834; K990903; and…	Instruments For Medicine and Diagnostics	1998	—
*	K003202	Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II Summary page 1 …Product Code: GEX Panel: 79 Predicate devices: Leg Veins: The HGM VeirLase 6981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd:YAG o(003765; KO10834; K990903; and K020463) are cited. Athoscan: The Hexas…	Altus Medical	2001	—
*	K003765	Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration) Summary page 1 …Panel: 79 Predicate devices: Leg Veins: The HGM VeirLase 6981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd:YAG o(003765; KO10834; K990903; and K020463) are cited. Athoscan: The Hexascan 6890865); Smartscan (M9…	Laserscope	2001	—
*	K010834	Lyra Series Surgical Laser System & Accessories	Laserscope	2001	—
*	K990903	Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) Summary page 1 …Panel: 79 Predicate devices: Leg Veins: The HGM VeirLase 6981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd:YAG o(003765; KO10834; K990903; and K020463) are cited. Athoscan: The Hexascan 6890865); Smartscan (M94 184 1); the Soft…	Laserscope	1999	—
*	K020463	Depilase Yag Lase Plus Laser System Summary page 1 …g Veins: The HGM VeirLase 6981952); the Altus Family of CoolGlide Lasers (K003202); and Lyra Nd:YAG o(003765; KO10834; K990903; and K020463) are cited. Athoscan: The Hexascan 6890865); Smartscan (M94 184 1); the SoftScan (K97102…	Depilase Group, Ltd.	2002	—
Kept off the family tree	K980865	FDA’s K980865 is Quickscreen Pro Multi Drug Screening Test , Model 9140-9147, 9061,9066, 9071… Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree	Phamatech	1998	—
*	K941841	Smartscan	Laserscope	1994	—
*	K971024	Softscan Summary page 1 …10834; K990903; and K020463) are cited. Athoscan: The Hexascan 6890865); Smartscan (M94 184 1); the SoftScan (K971024) the Jenascan (K980001); the Skinscan (K970757); and the Viridis Derrna Scanner (KO20071) are cited.’ === Pa…	Sahar Technologies, Inc.	1997	—
*	K980001	Jenascan Summary page 1 …K020463) are cited. Athoscan: The Hexascan 6890865); Smartscan (M94 184 1); the SoftScan (K971024) the Jenascan (K980001); the Skinscan (K970757); and the Viridis Derrna Scanner (KO20071) are cited.’…	Jenoptik Laser, Optik, Systeme GmbH	1998	—
*	K970757	Fotona Skinscan Summary page 1 …are cited. Athoscan: The Hexascan 6890865); Smartscan (M94 184 1); the SoftScan (K971024) the Jenascan (K980001); the Skinscan (K970757); and the Viridis Derrna Scanner (KO20071) are cited.’ Constans Cooling Sy…	Medical Laser Solutions	1997	—
*	K020071	Viridis Derma Laser	Quantel Medical	2002	—
*	K951033	Andela Dynamic Cooling Device Summary page 2 …Skinscan (K970757); and the Viridis Derrna Scanner (KO20071) are cited.’ Constans Cooling System: The Candela DCD (K95 1033); the Cynosure Dermatology Laser Cooling Tip ( K972002); the Laserscope CoolSpotm (K984 110…	Candela Laser Corp.	1996	—
*	K972002	Cynosure Dermatology Laser Cooling Tip Summary page 2 …0071) are cited.’ Constans Cooling System: The Candela DCD (K95 1033); the Cynosure Dermatology Laser Cooling Tip ( K972002); the Laserscope CoolSpotm (K984 110); the OptoMed, Inc. DermaCoolm (K9904 17); the EpiLaser…	Cynosure, Inc.	1997	—
*	K984110	Laserscope Coolspot Summary page 2 …nstans Cooling System: The Candela DCD (K95 1033); the Cynosure Dermatology Laser Cooling Tip ( K972002); the Laserscope CoolSpotm (K984 110); the OptoMed, Inc. DermaCoolm (K9904 17); the EpiLaser Normal Mode Ruby Laser [with cooling] ( K963947); and…	Laserscope	1998	—
*	K990417	Dermacool Summary page 2 …95 1033); the Cynosure Dermatology Laser Cooling Tip ( K972002); the Laserscope CoolSpotm (K984 110); the OptoMed, Inc. DermaCoolm (K9904 17); the EpiLaser Normal Mode Ruby Laser [with cooling] ( K963947); and the GentleLase I1 Derm…	Optomed Corp.	1999	—
*	K963947	Epilaser Normal Mode Ruby Laser Summary page 2 …the Laserscope CoolSpotm (K984 110); the OptoMed, Inc. DermaCoolm (K9904 17); the EpiLaser Normal Mode Ruby Laser [with cooling] ( K963947); and the GentleLase I1 Dermatology Laser - with DCD and hair removal claims (K984601) are…	Spectrum Medical Technologies, Inc.	1997	—
*	K984601	Candela Gentlelase II Dermatological Laser Summary page 2 …Laser Normal Mode Ruby Laser [with cooling] ( K963947); and the GentleLase I1 Dermatology Laser - with DCD and hair removal claims (K984601) are cited. Device description: The Athos laser emits a beam of coherent light at 1064 microns which is…	Candela Corp.	1999	—

Also cleared against K981952: 6 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 6 years and passes through 5 companies; a new generation was cleared every 12 months on median.
1 of the 42 ancestors has a recall of any class.
6 other devices also cite its predicate K981952.

How does its category compare?

All GEX devices

GEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEX

83in 2025

2007high 107 (2008) · low 41 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEX

90in 2025

2007high 152 (2022) · low 78 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEX

3in 2024

2007high 18 (2011) · low 0 (2009)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · GEX

2,720in 2025

2007high 3,525 (2018) · low 209 (2009)2025

MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	73	79	9	342
2008	107	86	2	232
2009	69	100	0	209
2010	50	96	4	1,711
2011	41	83	18	3,024
2012	45	118	5	2,000
2013	46	144	3	2,236
2014	61	147	6	2,036
2015	47	112	0	2,099
2016	51	114	1	2,585
2017	67	90	5 (1)	2,977
2018	51	78	5	3,525
2019	41	88	6	2,709
2020	52	90	1	2,183
2021	53	123	0	3,465
2022	60	152	0	2,288
2023	52	87	6	2,337
2024	82	90	3	2,187
2025	83	90	0	2,720
2026	57	90	2	—

What is it indicated for?

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.”

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021650 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021650: Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021650

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026