510(k) · Cleared

Cleared

Flex-Lase 600 Series Ion Laser System

K963389510(k) TraditionalCleared Nov 26, 199690-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

American Laser Medical · GEX Powered Laser Surgical Instrument

Cleared on Nov 26, 1996 as substantially equivalent to K913569 (Hgm Medical Laser Systems, Inc., 1991) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1990.

Decided: Nov 26, 1996
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K903883 (1990). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK903883 Vasculase (R) Copper Vapor Laser Syst, Pigment LesMetatech Corp. · 1990
This deviceK963389 Flex-Lase 600 Series Ion Laser SystemAmerican Laser Medical · 1996

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K903883	Vasculase (R) Copper Vapor Laser Syst, Pigment Les	Metatech Corp.	1990	—
0 (this device)	K963389	Flex-Lase 600 Series Ion Laser System	American Laser Medical	1996	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	1	0

FIG. 1 — Lineage of K963389, 1990–1996Source: 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

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What was it cleared against? (4)

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
Kept off the family tree	K913428	NGM Spectrum K1 Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 6 …(same) (same) (same) legions heman- hemangioma gioma, Strawberry Straw- hemangioma berry Telangec- heman- tasia gioma, Roeacea Telangec- tasia, Rosacea K Number K913428, K903883 na K913569 11,8836 ~ 18:57 3L 334 2352 Laser BEquivalency Table Pigmented Lesions NO. 655 M FLE…
*	K913569	Compac a, Elite a, Elite a Plus, Surgica a Summary page 6 …legions heman- hemangioma gioma, Strawberry Straw- hemangioma berry Telangec- heman- tasia gioma, Roeacea Telangec- tasia, Rosacea K Number K913428, K903883 na K913569 11,8836 ~ 18:57 3L 334 2352 Laser BEquivalency Table Pigmented Lesions NO. 655 M FLEXI-LASE \| FLEX-LASE H…	Hgm Medical Laser Systems, Inc.	1991	1
*	K903883	Vasculase (R) Copper Vapor Laser Syst, Pigment Les Summary page 6 …same) (same) legions heman- hemangioma gioma, Strawberry Straw- hemangioma berry Telangec- heman- tasia gioma, Roeacea Telangec- tasia, Rosacea K Number K913428, K903883 na K913569 11,8836 ~ 18:57 3L 334 2352 Laser BEquivalency Table Pigmented Lesions NO. 655 M FLEXI-LASE \|…	Metatech Corp.	1990	—
*	—	Coherent Artisan Named without a submission number			—

Also cleared against K913569: 1 other device →

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?

1 of the 2 ancestors has a recall of any class.
1 other device also cites its predicate K913569.

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 Flex-lase 600 Ion Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are: Flex-Lase Model 640 Laser System For vascular lesions: (Yellow - 568 nm) 1. Capillary Hemangioma (port wine hemangioma) 2. Strawberry hemangioma 3. Telangectasia 4. Rosacea For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm) Freckles Age Spots Cafe-au-lait Lentigo Flex-Lase Model…

Read the full statement (110 words)

The Flex-lase 600 Ion Laser is intended for use in the treatment of selected pigmented and vascularized lesions of the skin. Representative indications for use are:

Flex-Lase Model 640 Laser System

For vascular lesions: (Yellow - 568 nm)

1. Capillary Hemangioma (port wine hemangioma)

2. Strawberry hemangioma

3. Telangectasia

4. Rosacea

For pigmented lesions: (Yellow/Green - 568 nm and 520-530 nm)

Freckles

Age Spots

Cafe-au-lait

Lentigo

Flex-Lase Model 620 Laser System

For Vascular lesions: (Blue/Green - 488 nm and 514.5 nm)

1. Capillary Hemangioma (port wine hemangioma)

2. Strawberry Hemangioma

3. Telangectasia

4. Rosacea

For pigmented lesions: (Green - 514.5 nm)

1. Freckles

2. Age Spots

3. Cafe-au-lait

4. Lentigo

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K963389 · printed Nov 5, 2026

Cite this page

510(k) Report. “K963389: Flex-Lase 600 Series Ion Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K963389

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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