510(k) · Cleared

Cleared

Microlight 830 Laser System

K010175510(k) TraditionalCleared Feb 6, 2002384-day reviewClass II21 CFR 890.5500

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

Microlight Corporation of America · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Cleared on Feb 6, 2002 after a 384-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 88 later devices descend from it.

Decided: Feb 6, 2002
Review: 384 days
Class: Class II
Product code: NHN
Recalls: None
Predicates: 0

88 later devices descend from it, 11 citing it directly.

This deviceK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
Descendant · cites it directly · 65 of its ownK030692 Power Laser 90Andi Electromedical Aps · 2003
Descendant · 2 generations on · 63 of its ownK070516 PowerlaserPowermedic Aps · 2007
Descendant · 3 generations on · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
Descendant · 4 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
Descendant · 4 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2002high 10 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 88 · See all

K030692Power Laser 90Andi Electromedical Aps · 2003 · cites it directly65descendants
K070516PowerlaserPowermedic Aps · 2007 · 2 generations on63descendants
K083595EzlaseBiolase Technology, Inc. · 2009 · 3 generations on58descendants
K121286EPIC 10Biolase Technology, Inc. · 2012 · 4 generations on31descendants
K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 4 generations on25descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010175	Microlight 830 Laser System	Microlight Corporation of America	2002	—
+1	K030692	Power Laser 90	Andi Electromedical Aps	2003	—
+2	K070516	Powerlaser	Powermedic Aps	2007	—
+3	K083595	Ezlase	Biolase Technology, Inc.	2009	—
+4	K121286	EPIC 10	Biolase Technology, Inc.	2012	—
+4	K123971	Cynosure 1064NM Diode Laser	Cynosure, Inc.	2013	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	2	0
2003	5	0
2004	1	0
2005	2	0
2006	1	0
2007	2	0
2008	4	0
2009	2	0
2010	1	0
2011	1	0
2012	1	0
2013	1	0
2014	2	0
2015	3	0
2016	5	0
2017	3	0
2018	3	0
2019	4	0
2020	5	0
2021	4	0
2022	8	0
2023	5	0
2024	8	0
2025	10	0
2026	5	0

FIG. 1 — Lineage of K010175, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Planning a device in NHN? 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 NHN device

#1 K241057 Enhanced Handheld Pain Relief Laser Instrument…score 12.9 · 5 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (88)

See all 88

11 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K030692	Power Laser 90	Andi Electromedical Aps	2003	65
K020657	Acculaser Pro Low Level Laser Therapy Device	Acculaser, Inc.	2002	19
K050668	GRT Lite, Model 8-a	Grt Solutions, Inc.	2006	9
K021985	Medx LCS Laser Series	Medx Electronics, Inc.	2002	9
K030226	Thor Ddii 830CL3 Laser System	Thor Intl.	2003	6
K023060	Acculaser PRO4	Acculaser, Inc.	2004	2
K034009	LAPEX 2000	Meridian Co., Ltd.	2005	1
K072551	LD-I 75 and LD-I 200	Meditech International, Inc.	2008	0
K063574	Luminex LL Laser System	Medical Laser Systems, Inc.	2007	0
K033015	Axiom Biolaser LLLT Series-3	Axiom Usa., Inc.	2003	0

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?

Of its descendants, K030692 (Andi Electromedical Aps, 2003) has gone furthest, with 65 descendants of its own.

How does its category compare?

All NHN devices

NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · NHN

2in 2025

2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHN

416in 2022

2007high 416 (2022) · low 117 (2018)2026

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

Recalls per year · NHN

2in 2019

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHN

1in 2025

2007high 1 (2010) · low 0 (2007)2025

MAUDE reports naming product code NHN, 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	1	—	0	0
2008	3	260	0	0
2009	2	—	0	0
2010	2	—	0	1
2011	0	—	0	0
2012	0	—	0	0
2013	2	—	0	0
2014	1	—	0	0
2015	1	—	0	0
2016	3	154	0	0
2017	0	—	0	0
2018	3	117	0	0
2019	2	—	2	1
2020	0	—	0	0
2021	2	—	0	1
2022	3	416	0	0
2023	1	—	0	0
2024	1	—	0	0
2025	2	—	0	1
2026	2	—	0	—

https://510kreport.com/device/K010175 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010175: Microlight 830 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010175

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026