510(k) · Cleared

Cleared

Scantech Laser Scanner

K974633510(k) TraditionalCleared Jan 16, 199835-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

Phantom Technologies, Inc. · GEX Powered Laser Surgical Instrument

Cleared on Jan 16, 1998 as substantially equivalent to K960032 (Coherent Medical Group, 1996) and 11 other predicates after a 35-day review. Its family tree reaches back 3 generations to 1996.

Decided: Jan 16, 1998
Review: 35 days
Class: Class II
Product code: GEX
Recalls: None
Predicates: 12

Its longest line of descent runs back 3 generations to K955734 (1996). 27 ancestors in all, the oldest K904627 (1991). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
2 generations backK962242 SurescanClinicon Corp. · 1996
1 generation backK964684 SoftouchSahar Technologies, Inc. · 1997
This deviceK974633 Scantech Laser ScannerPhantom Technologies, Inc. · 1998

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K955734	Lasersonics Parascan Dosimeter Device	Heraeus Surgical, Inc.	1996	—
−2	K962242	Surescan	Clinicon Corp.	1996	—
−1	K964684	Softouch	Sahar Technologies, Inc.	1997	—
0 (this device)	K974633	Scantech Laser Scanner	Phantom Technologies, Inc.	1998	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1991	3	0
1993	2	0
1994	9	0
1995	4	0
1996	5	0
1997	1	0

FIG. 1 — Lineage of K974633, 1996–1998Source: 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? (12)

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
*	K960032	Coherent Versapulse Aesthetic Surgical Lasers Summary page 2 …r his/her assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k95…	Coherent Medical Group	1996	—
*	K951812	Modified Coherent Ultrapulse CO2 Surgical Lasers Summary page 2 …assistant, will select the desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The…	Lumenis, Inc.	1995	—
*	K946304	Coherent Family of CO2 Surgical Laser Scanner Handpieces Our OCR of the scanned summary read K943604, FDA’s number for Integral V Biointegrated Dental Implant System (Calcitek, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Coherent”.	Lumenis, Inc.	1995	—
*	K962242	Surescan Summary page 2 …desired shape, size and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning ha…	Clinicon Corp.	1996	—
*	K964520	Parascan Scanning Device Summary page 2 …and density, as well as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed…	Laserscope	1997	—
*	K955734	Lasersonics Parascan Dosimeter Device Summary page 2 …ity, as well as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use i…	Heraeus Surgical, Inc.	1996	—
*	K941841	Smartscan Summary page 2 …ell as other operating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgica…	Laserscope	1994	—
*	K964684	Softouch Summary page 2 …erating parameters, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgical applications…	Sahar Technologies, Inc.	1997	—
*	K961935	Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner Summary page 2 …, from the Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the exci…	Sharplan Lasers, Inc.	1996	—
*	K960820	Sharplan Lasers, Inc. Silktouch XJ Scanner Summary page 2 …e Phantom laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, inc…	Sharplan Lasers, Inc.	1996	—
*	K960521	Sharplan Lasers, Inc. Silktouch Flash Scanner Summary page 2 …laser's interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ab…	Sharplan Lasers, Inc.	1996	—
*	K955621	Sharplan Lasers, Inc Silktouch 2 Flash Scanner Summary page 2 …interactive touch screen. Coherent k960032, k951812, k943604 Clinicon k962242 Laserscope k964520, k955734, k941841 Sahar k964684 Sharplan k961935, k960820, k960521, k955621 The ScanTech laser scanning handpiece is designed for use in surgical applications requiring the excision, incision, ablation, v…	Sharplan Lasers, Inc.	1996	—

Also cleared against K960032: 5 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 2 years and passes through 4 companies; a new generation was cleared every 7 months on median.
None of the 27 ancestors has a recall.
5 other devices also cite its predicate K960032.

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 ScanTech laser scanning handpiece is designed for use in surgical applications requirdng the exdision, incision, ablation, vaporization, and coaguiation and photo thermolysis of soft lissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, demnatology, ophthalmology (imited to periobital demmis).

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/K974633 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974633: Scantech Laser Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974633

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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