510(k) · Cleared

Cleared

International Biophysics Corporation (Ibc) Laser Peel System

K030181510(k) TraditionalCleared Apr 17, 200390-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

International Biophysics Corp. · GEX Powered Laser Surgical Instrument

Cleared on Apr 17, 2003 as substantially equivalent to K954013 (Schwartz Electro-Optics, Inc., 1996) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996.

Decided: Apr 17, 2003
Review: 90 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K954013 (1996). 6 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 4 generations backK954013 Trilase 2940 Erbium LaserSchwartz Electro-Optics, Inc. · 1996
3 generations backK961748 Medlite/Erbium Laser SystemContinuum Biomedical, Inc. · 1996
2 generations backK980361 Dermablate ER: Yag Laser SystemAesculap-Meditec North America · 1998
1 generation backK014057 Dermastar ER:Yag Laser SystemAsclepion-Meditec AG · 2002
This deviceK030181 International Biophysics Corporation (Ibc) Laser Peel SystemInternational Biophysics Corp. · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	1996	—
−3	K961748	Medlite/Erbium Laser System	Continuum Biomedical, Inc.	1996	—
−2	K980361	Dermablate ER: Yag Laser System	Aesculap-Meditec North America	1998	—
−1	K014057	Dermastar ER:Yag Laser System	Asclepion-Meditec AG	2002	—
0 (this device)	K030181	International Biophysics Corporation (Ibc) Laser Peel System	International Biophysics Corp.	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	2	0

FIG. 1 — Lineage of K030181, 1996–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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? (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
*	K954013	Trilase 2940 Erbium Laser	Schwartz Electro-Optics, Inc.	1996	—
*	K970461	Cell Robotics ER: Yag Surgical Laser Summary page 1 …21 CFR 878-48 Legally Marketed Predicate Schwartz Electro-Optics TriLase 2940, K#9540 13 Device Cell Robotics Er:YAG Laser System, K#970461 Asceplion-Meditec Dermastar Er:YAG Laser System, K#O 14057 Description of the Device T…	Cell Robotics, Inc.	1997	—
*	K014057	Dermastar ER:Yag Laser System	Asclepion-Meditec AG	2002	—

Also cleared against K954013: 13 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 7 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
None of the 6 ancestors has a recall.
13 other devices also cite its predicate K954013.

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 International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K030181 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030181: International Biophysics Corporation (Ibc) Laser Peel System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030181

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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