510(k) · Cleared
ClearedSoftscan
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sahar Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 17, 1997 as substantially equivalent to K962242 (Clinicon Corp., 1996) and 1 other predicate after an 89-day review. Its family tree reaches back 2 generations to 1996. 3 later devices descend from it.
- Decided
- Jun 17, 1997
- Review
- 89 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955734 (1996). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
- 1 generation backK962242 SurescanClinicon Corp. · 1996
- This deviceK971024 SoftscanSahar Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK021650 Athoscan for the Athos Laser Constans Cooling Hand Piece for the…Quantel Medical · 2002
- Descendant · cites it directly · 0 of its ownK982295 Nidek LightscanNidek, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK980784 SuretouchSahar Technologies, Inc. · 1998
Most influential descendants
Showing 3 of 3 · See allView 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) | K971024 | Softscan | Sahar Technologies, Inc. | 1997 | — |
| +1 | K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | Quantel Medical | 2002 | — |
| +1 | K982295 | Nidek Lightscan | Nidek, Inc. | 1998 | — |
| +1 | K980784 | Suretouch | Sahar Technologies, Inc. | 1998 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 2 | 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 |
|---|---|---|---|
| * | K962242 | SurescanSummary page 1…Trade name: SoftScan ( Common name: Laser Accessory Classification name: Class II Substantial equivalence claimed to: 1. Clinicon Corporation SureScan 510(k) number - K962242 2. Lasersonics Parascan - 510(k) number - K955734 Description: Adding the SoftScan to any laser will convert the system into a… | 1996 |
| * | K955734 | Lasersonics Parascan Dosimeter DeviceSummary page 1…ory Classification name: Class II Substantial equivalence claimed to: 1. Clinicon Corporation SureScan 510(k) number - K962242 2. Lasersonics Parascan - 510(k) number - K955734 Description: Adding the SoftScan to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool t… | 1996 |
What descends from it? (3)
3 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?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 9 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K021650 (Quantel Medical, 2002) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K962242.
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?
SoftScan will be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.
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/K971024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971024: Softscan.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971024
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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