510(k) · Cleared
ClearedSurescan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Clinicon Corp. · GEX Powered Laser Surgical Instrument
Cleared on Sep 3, 1996 as substantially equivalent to K955734 (Heraeus Surgical, Inc., 1996) after an 84-day review. Its family tree reaches back 1 generation to 1996. 11 later devices descend from it.
- Decided
- Sep 3, 1996
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K955734 (1996). 11 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
- This deviceK962242 SurescanClinicon Corp. · 1996
- Descendant · cites it directly · 6 of its ownK964684 SoftouchSahar Technologies, Inc. · 1997
- Descendant · cites it directly · 3 of its ownK971024 SoftscanSahar Technologies, Inc. · 1997
- Descendant · 2 generations on · 0 of its ownK021650 Athoscan for the Athos Laser Constans Cooling Hand Piece for the…Quantel Medical · 2002
- Descendant · 2 generations on · 0 of its ownK980398 Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998
- Descendant · 2 generations on · 0 of its ownK982295 Nidek LightscanNidek, Inc. · 1998
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K964684SoftouchSahar Technologies, Inc. · 1997 · cites it directly6descendants
- K971024SoftscanSahar Technologies, Inc. · 1997 · cites it directly3descendants
- K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical · 2002 · 2 generations on0descendants
- K980398Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998 · 2 generations on0descendants
- K982295Nidek LightscanNidek, Inc. · 1998 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K955734 | Lasersonics Parascan Dosimeter Device | Heraeus Surgical, Inc. | 1996 | — |
| 0 (this device) | K962242 | Surescan | Clinicon Corp. | 1996 | — |
| +1 | K964684 | Softouch | Sahar Technologies, Inc. | 1997 | — |
| +1 | K971024 | Softscan | Sahar Technologies, Inc. | 1997 | — |
| +2 | K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | Quantel Medical | 2002 | — |
| +2 | K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | Optomedic Medical Technologies, Ltd. | 1998 | — |
| +2 | K982295 | Nidek Lightscan | Nidek, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 6 | 0 |
| 1998 | 4 | 0 |
| 2002 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K955734 | Lasersonics Parascan Dosimeter DeviceSummary page 1…e 6, 1996 - Trade name: SureScan Common name: Laser Accessory Classification name: Class 11 Substantial equivalence claimed to: 1. Lasersonics Parascan - 510(k) number - K955734 2. Coherent Computerized Pattern Generator Description: SureScan converts any CO, laser, pulsed or CW, into a sophisticated aesth… | 1996 |
| * | — | Coherent Computerized Pattern Generator Named without a submission number |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 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?
SureScan may be used for a varety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. Using advanced software control, SureScan juxtaposes laser beam spots with precisely controlled amounts of spatial overlap and time between overlap spots. Highly controlled tissue ablation is achieved with…
Read the full statement (168 words)
SureScan may be used for a varety of soft tissue ablation procedures where precise removal is required to minimize damage to adjacent or underlying tissue layers. SureScan employs a microprocessor controlled, mirror system for scanning the laser beam. Using advanced software control, SureScan juxtaposes laser beam spots with precisely controlled amounts of spatial overlap and time between overlap spots. Highly controlled tissue ablation is achieved with minimal thermal injury. The microprocessor controlled fail-safe system eliminates potential hazards because the operation is controlled via an existing laser footswitch, so there is no interference with the internal electronics or workings of the laser. SureScan allows for realignment of a laser beam due to an out of calibration articulated arm. As a result, the physician is always assured of optimum beam quality and mode as it exits the SureScan Device. If the beam characteristics of the laser do not meet the control standards of the SureScan system, an audible warning is provided to the operator and the laser footswitch rendered inoperative.
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/K962242 · printed Nov 4, 2026
Cite this page
510(k) Report. “K962242: Surescan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K962242
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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