510(k) · Cleared
ClearedSoftouch
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 Feb 14, 1997 as substantially equivalent to K962242 (Clinicon Corp., 1996) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1996. 6 later devices descend from it.
- Decided
- Feb 14, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K955734 (1996). 6 later devices descend from it, 6 citing it directly.
- Root · 2 generations backK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
- 1 generation backK962242 SurescanClinicon Corp. · 1996
- This deviceK964684 SoftouchSahar Technologies, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK980398 Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998
- Descendant · cites it directly · 0 of its ownK980784 SuretouchSahar Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK974633 Scantech Laser ScannerPhantom Technologies, Inc. · 1998
- Descendant · cites it directly · 0 of its ownK972028 Dermascan Surgical Laser ScannerEsc Medical Systems, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK971903 Scanning Device Accessory for Use with the CB Diode/532 ND:Yag LaserContinuum Biomedical, Inc. · 1997
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K980398Kaplan Pendulaser 115 Surgical Laser with Optoscan IIOptomedic Medical Technologies, Ltd. · 1998 · cites it directly0descendants
- K980784SuretouchSahar Technologies, Inc. · 1998 · cites it directly0descendants
- K974633Scantech Laser ScannerPhantom Technologies, Inc. · 1998 · cites it directly0descendants
- K972028Dermascan Surgical Laser ScannerEsc Medical Systems, Ltd. · 1997 · cites it directly0descendants
- K971903Scanning Device Accessory for Use with the CB Diode/532 ND:Yag LaserContinuum Biomedical, Inc. · 1997 · cites it directly0descendants
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) | K964684 | Softouch | Sahar Technologies, Inc. | 1997 | — |
| +1 | K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | Optomedic Medical Technologies, Ltd. | 1998 | — |
| +1 | K980784 | Suretouch | Sahar Technologies, Inc. | 1998 | — |
| +1 | K974633 | Scantech Laser Scanner | Phantom Technologies, Inc. | 1998 | — |
| +1 | K972028 | Dermascan Surgical Laser Scanner | Esc Medical Systems, Ltd. | 1997 | — |
| +1 | K971903 | Scanning Device Accessory for Use with the CB Diode/532 ND:Yag Laser | Continuum Biomedical, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
| 1998 | 3 | 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…d: November 12, 1996 Trade name: SofTouch Common name: Laser Accessory mm:cun@,\ Substantial equivalence claimed to: 1. Climicon Corporation Surefican 510¢k) sumber - K962242 2. Lasersonics Perascan - 510(k) mumber - K955734 Description: Adding the SofTouch to any laser will convert the system into a… | 1996 |
| * | K955734 | Lasersonics Parascan Dosimeter DeviceSummary page 1…name: Laser Accessory mm:cun@,\ Substantial equivalence claimed to: 1. Climicon Corporation Surefican 510¢k) sumber - K962242 2. Lasersonics Perascan - 510(k) mumber - K955734 Description: Adding the SofTouch to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool t… | 1996 |
What descends from it? (6)
6 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K980398 | Kaplan Pendulaser 115 Surgical Laser with Optoscan II | 1998 | 0 |
| K980784 | Suretouch | 1998 | 0 |
| K974633 | Scantech Laser Scanner | 1998 | 0 |
| K972028 | Dermascan Surgical Laser Scanner | 1997 | 0 |
| K971903 | Scanning Device Accessory for Use with the CB Diode/532 ND:Yag Laser | 1997 | 0 |
| K971879 | Scanning Device Accessory for Use with the CB Erbium/2.94 ER:Yag Laser | 1997 | 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?
- The line of descent spans 1 year and passes through 3 companies; a new generation was cleared every 7 months on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K980398 (Optomedic Medical Technologies, Ltd., 1998) 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?
@W&Wadmx&atmwv« large variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area enhances the precision and safety of the treatment. The…
Read the full statement (128 words)
@W&Wadmx&atmwv«
large variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area enhances the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.
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/K964684 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964684: Softouch.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964684
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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