510(k) · Cleared

Cleared

Laser System Mediostar H (with and Without Skin Cooling System)

K994116510(k) TraditionalCleared Jun 1, 2000178-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

Aesculap-Meditec North America · GEX Powered Laser Surgical Instrument

Cleared on Jun 1, 2000 as substantially equivalent to K982940 (Star Medical Technologies, Inc., 1999) and 2 other predicates after a 178-day review. Its family tree reaches back 5 generations to 1996.

Decided: Jun 1, 2000
Review: 178 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 5 generations to K963094 (1996). 14 ancestors in all, the oldest K950019 (1995). No later device cites it as a predicate yet.

By dateBy generation

Root · 5 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
4 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
3 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
2 generations backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
1 generation backK984601 Candela Gentlelase II Dermatological LaserCandela Corp. · 1999
This deviceK994116 Laser System Mediostar H (with and Without Skin Cooling System)Aesculap-Meditec North America · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K963094	Cynosure Photogenica LP Dermatological Vascular Lesion Laser	Cynosure, Inc.	1996	—
−4	K972767	Candela Gentlelase GL Dermatological Vascular Lesion Laser	Candela Corp.	1997	1
−3	K974381	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−2	K981351	Candela Gentlelase GL Dermatological Laser	Candela Corp.	1998	—
−1	K984601	Candela Gentlelase II Dermatological Laser	Candela Corp.	1999	—
0 (this device)	K994116	Laser System Mediostar H (with and Without Skin Cooling System)	Aesculap-Meditec North America	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
1996	1	0
1997	5	0
1999	2	0

FIG. 1 — Lineage of K994116, 1996–2000Source: 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? (3)

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.

Type	Number	Device	Applicant	Decided	Recalls
*	K982940	Lightsheer Pulsed Diode Array Laser System Summary page 1 …in general and plastic surgery and in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79 Coherent / Palomar - LightSheer ( K982940 ) LASERSCORPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE Il DERMATOLOGICAL LASER ( K984601 ) The laser system MeDioStar H…	Star Medical Technologies, Inc.	1999	—
*	K990903	Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration) Summary page 1 …nd in dermatology (21 CFR 878.4810) Product code: GEX - Laser instrument, surgical, powered Panel: 79 Coherent / Palomar - LightSheer ( K982940 ) LASERSCORPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE Il DERMATOLOGICAL LASER ( K984601 ) The laser system MeDioStar H operates as a pulsed diode lase…	Laserscope	1999	—
*	K984601	Candela Gentlelase II Dermatological Laser Summary page 1 …trument, surgical, powered Panel: 79 Coherent / Palomar - LightSheer ( K982940 ) LASERSCORPE - Lyra ( K990903 ) Candela - CANDELA GENTLELASE Il DERMATOLOGICAL LASER ( K984601 ) The laser system MeDioStar H operates as a pulsed diode laser which emits a beam of coherent light at 808 nanometers. The las…	Candela Corp.	1999	—

Also cleared against K982940: 10 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 4 years and passes through 3 companies; a new generation was cleared every 7 months on median.
1 of the 14 ancestors has a recall of any class.
10 other devices also cite its predicate K982940.

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 laser system MeDioStar H (with and without skin cooling system) is intended to remove unwanted body hair and vascular lesions.

The laser system MeDioStar H is restricted to sale to or use by licensed professionals in the United States.

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/K994116 · printed Nov 4, 2026

Cite this page

510(k) Report. “K994116: Laser System Mediostar H (with and Without Skin Cooling System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994116

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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