510(k) · Cleared

Cleared

Surgitron Radiolase

K992382510(k) TraditionalCleared Oct 14, 199990-day reviewClass II21 CFR 878.4400

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

Ellman Intl., Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on Oct 14, 1999 as substantially equivalent to K980177 (Ellman Intl., Inc., 1998) and 1 other predicate after a 90-day review. Its family tree reaches back 1 generation to 1994. 7 later devices descend from it.

Decided: Oct 14, 1999
Review: 90 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K933157 (1994). 2 ancestors in all. 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
This deviceK992382 Surgitron RadiolaseEllman Intl., Inc. · 1999
Descendant · cites it directly · 5 of its ownK014216 Secca SystemCuron Medical, Inc. · 2002
Descendant · 2 generations on · 3 of its ownK110143 Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011
Descendant · 3 generations on · 2 of its ownK121085 Het Bipolar Ligator SystemHet Systems, LLC · 2012
Descendant · 4 generations on · 1 of its ownK140422 Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014
Descendant · 5 generations on · 0 of its ownK200146 HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2002high 2 (2011) · low 0 (2003)2026

Most influential descendants

Showing 5 of 7 · See all

K014216Secca SystemCuron Medical, Inc. · 2002 · cites it directly5descendants
K110143Het Bipolar Electrocautery ForcepsHet Systems, LLC · 2011 · 2 generations on3descendants
K121085Het Bipolar Ligator SystemHet Systems, LLC · 2012 · 3 generations on2descendants
K140422Het Systems, LLC, Het Bipolar Ligator SystemHet Systems, LLC · 2014 · 4 generations on1descendant
K200146HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery MonitorCovidien, LLC · 2020 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K933157	Erbotom Icc 200	Erbe USA, Inc.	1994	—
0 (this device)	K992382	Surgitron Radiolase	Ellman Intl., Inc.	1999	—
+1	K014216	Secca System	Curon Medical, Inc.	2002	—
+2	K110143	Het Bipolar Electrocautery Forceps	Het Systems, LLC	2011	—
+3	K121085	Het Bipolar Ligator System	Het Systems, LLC	2012	—
+4	K140422	Het Systems, LLC, Het Bipolar Ligator System	Het Systems, LLC	2014	—
+5	K200146	HET Bipolar Electrocautery Forceps, HET Bipolar Electrocautery Monitor	Covidien, LLC	2020	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2011	2	0
2012	1	0
2014	1	0
2020	1	0

FIG. 1 — Lineage of K992382, 1994–2020Source: 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 GEI? 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 GEI device

#1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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? (2)

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
*	K980177	Sugitron Model: Iec Summary page 1 …copic Procedures. 4.3. Hemostasis Control of Bleeding, Epilation, Telangiectasia 5. Identification to predicate devices 5.1. Surgitron IEC with general use indication K980177 5.2. ERBOTOM ICC 200 with indication K933157 6. Summary of the technological characteristics of the new device i…	Ellman Intl., Inc.	1998	—
*	K933157	Erbotom Icc 200 Summary page 1 …Bleeding, Epilation, Telangiectasia 5. Identification to predicate devices 5.1. Surgitron IEC with general use indication K980177 5.2. ERBOTOM ICC 200 with indication K933157 6. Summary of the technological characteristics of the new device in comparison to the predicate devices Substa…	Erbe USA, Inc.	1994	—

Also cleared against K980177: 2 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K014216	Secca System	Curon Medical, Inc.	2002	5
K042710	Surgitron Radiolase II	Ellman Int'L, Inc.	2005	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?

None of the 2 ancestors has a recall.
Of its descendants, K014216 (Curon Medical, Inc., 2002) has gone furthest, with 5 descendants of its own.
2 other devices also cite its predicate K980177.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, 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	50	51	21	2,795
2008	61	71	19	2,556
2009	42	130	27	3,591
2010	46	109	51	3,377
2011	35	135	32	4,463
2012	39	133	30	5,216
2013	48	136	13	4,897
2014	49	103	3	4,908
2015	47	123	4	4,936
2016	64	108	3	5,616
2017	52	72	2	6,073
2018	47	93	6	6,545
2019	48	93	5	7,067
2020	59	105	1	6,490
2021	46	146	6	6,354
2022	55	150	49	6,103
2023	65	104	27 (4)	7,176
2024	59	125	22 (10)	7,897
2025	52	113	4	7,592
2026	43	183	8	—

What is it indicated for?

is idendical to the Surgitron as a preammendment device such as:

Cutting

Skin Incisions, Biopsy, Cysts, Abscesses, Tumors, Cosmetic Repairs, Development of Skin Flaps, SkinTags, Nevi, Keratosis, Oculoplastic Procedures, Blepharoplasty, Aponeurotic Repair, Levator Resection, Arthrosgopic Procedures.

Blended Cutting and Coagulation

Skin Tags, Papilloma Keloids, Keratosis, Verrucae, Basal CellCarcinoma, Nevi, Fistulas, Epithelioma, Cosmetic Repairs, Cysts, Abscesses, Development of Skin Flaps, Oculoplastic Procedures, Arthroscopic Procedures.

Hemostasis

Control of Bleeding, Epilation, Telangiectasia

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/K992382 · printed Nov 5, 2026

Cite this page

510(k) Report. “K992382: Surgitron Radiolase.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K992382

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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