510(k) · Cleared
ClearedLasersonics Parascan Dosimeter Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Heraeus Surgical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 13, 1996 after a 57-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 14 later devices descend from it.
- Decided
- Feb 13, 1996
- Review
- 57 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
14 later devices descend from it, 7 citing it directly.
- This deviceK955734 Lasersonics Parascan Dosimeter DeviceHeraeus Surgical, Inc. · 1996
- Descendant · cites it directly · 11 of its ownK962242 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 · cites it directly · 1 of its ownK964520 Parascan Scanning DeviceLaserscope · 1997
- Descendant · 2 generations on · 0 of its ownK021650 Athoscan for the Athos Laser Constans Cooling Hand Piece for the…Quantel Medical · 2002
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K962242SurescanClinicon Corp. · 1996 · cites it directly11descendants
- K964684SoftouchSahar Technologies, Inc. · 1997 · cites it directly6descendants
- K971024SoftscanSahar Technologies, Inc. · 1997 · cites it directly3descendants
- K964520Parascan Scanning DeviceLaserscope · 1997 · cites it directly1descendant
- K021650Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos LaserQuantel Medical · 2002 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955734 | Lasersonics Parascan Dosimeter Device | Heraeus Surgical, Inc. | 1996 | — |
| +1 | K962242 | Surescan | Clinicon Corp. | 1996 | — |
| +1 | K964684 | Softouch | Sahar Technologies, Inc. | 1997 | — |
| +1 | K971024 | Softscan | Sahar Technologies, Inc. | 1997 | — |
| +1 | K964520 | Parascan Scanning Device | Laserscope | 1997 | — |
| +2 | K021650 | Athoscan for the Athos Laser Constans Cooling Hand Piece for the Athos Laser | Quantel Medical | 2002 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 8 | 0 |
| 1998 | 4 | 0 |
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (14)
See all 147 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?
- Of its descendants, K962242 (Clinicon Corp., 1996) has gone furthest, with 11 descendants of its own.
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 | — |
https://510kreport.com/device/K955734 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955734: Lasersonics Parascan Dosimeter Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955734
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026