510(k) · Cleared

Cleared

Surescan

K964831510(k) TraditionalCleared Aug 8, 1997249-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

Clinicon Corp. · GEX Powered Laser Surgical Instrument

Cleared on Aug 8, 1997 as substantially equivalent to K901008 (Lihtan Technologies, Inc., 1990) and 1 other predicate after a 249-day review. Its family tree reaches back 2 generations to 1996.

Decided: Aug 8, 1997
Review: 249 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 2

Its longest line of descent runs back 2 generations to K955734 (1996). 3 ancestors in all, the oldest K901008 (1990). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
1 generation backK962242 SurescanClinicon Corp. · 1996
This deviceK964831 SurescanClinicon Corp. · 1997

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K955734	Lasersonics Parascan Dosimeter Device	Heraeus Surgical, Inc.	1996	—
−1	K962242	Surescan	Clinicon Corp.	1996	—
0 (this device)	K964831	Surescan	Clinicon Corp.	1997	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0

FIG. 1 — Lineage of K964831, 1996–1997Source: 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

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
*	K901008	Hexascan Handpiece Summary page 1 …26", 1996 Trade Name: SureScan Common Name: Laser Accessory _ Classification Name: Class II Substantial Equivalence Claimed To: 1. Hexascan - Lithan Techn. Inc. 510(k) # K 901008 2. CPG - Coherent Medical Inc 510(k) # not known 3. SureScan - Clinicon Corp. 510(k) # K 962242 Description: SureScan adapts to…	Lihtan Technologies, Inc.	1990	—
*	K962242	Surescan Summary page 1 …antial Equivalence Claimed To: 1. Hexascan - Lithan Techn. Inc. 510(k) # K 901008 2. CPG - Coherent Medical Inc 510(k) # not known 3. SureScan - Clinicon Corp. 510(k) # K 962242 Description: SureScan adapts to laser systems with wavelengths in the visible spectrum from 430nm to 700nm ( blue, green, yellow…	Clinicon Corp.	1996	—
*	—	CPG - Coherent Medical Inc Named without a submission number			—

Also cleared against K901008: 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?

The line of descent spans 1 year and passes through 2 companies; a new generation was cleared every 11 months on median.
None of the 3 ancestors has a recall.
1 other device also cites its predicate K901008.

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?

CAUTION SureScan use is restricted for adaptation to laser systems that have received FDA clearance for cutaneous surgical applications and soft tissue ablation at the following specific wavelengths: 488nm, 511nm, 514nm, 520nm, 530nm, 532nm, 568nm, 577nm, 578nm, 585nm, 694nm, 752nm, 1064nm, 2940nm. Users should refer to the laser manufacturer’s operating manual for applications that have been cleared for the specific wavelength. SureScan Wavelengths &…

Read the full statement (182 words)

CAUTION

SureScan use is restricted for adaptation to laser systems that have received FDA clearance for cutaneous surgical applications and soft tissue ablation at the following specific wavelengths: 488nm, 511nm, 514nm, 520nm, 530nm, 532nm, 568nm, 577nm, 578nm, 585nm, 694nm, 752nm, 1064nm, 2940nm. Users should refer to the laser manufacturer’s operating manual for applications that have been cleared for the specific wavelength.

SureScan Wavelengths & Indications for Use

(Consult Manufacturer’s Manual for Cleared Applications)

488nm Blue/Green CWArgon Epidermal vascular lesions

511nm Green Pulsed Copper Vapor Epidermal vascular lesions

514nm Green CWArgon Epidermal vascular lesions

520nm Green CWKrypton Epidermal vascular lesions

530nm Green CWKrypton Epidermal vascular & Pigm. Lesions

532nm Green CW/Pulsed KTP YAG Epidermal vascular & Pigm. Lesions

568nm Yellow CWKrypton Epidermal vascular & Pigm. Lesions

577nm Yellow CWDye Epidermal vascular & Pigm. Lesions

578nm Yellow Pulsed Copper Vapor Epidermal vascular & Pigm. Lesions

585nm Yellow CWDye Epidermal vascular & Pigm. Lesions

694nm Red Pulsed Ruby Epid. Pigm. Lesions & Tattoos

752nm Red Pulsed Alexandrite Epid. Pigm. Lesions & Tattoos

1064nm IR Pulsed Nd:YAG Epidermal Pigmented Lesions

2940nm IR CWErYAG Soft Tissue Ablation

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/K964831 · printed Nov 4, 2026

Cite this page

510(k) Report. “K964831: Surescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964831

Report an extraction error

Are you the manufacturer?

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