510(k) · Cleared
ClearedKelsey Intersitital Laser Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kelsey, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 2, 2007 as substantially equivalent to K012398 (Diomed, Ltd., 2002) and 3 other predicates after an 85-day review. Its family tree reaches back 8 generations to 1995. 1 later device descends from it.
- Decided
- May 2, 2007
- Review
- 85 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 8 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 6 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 5 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 4 generations backK971532 Arthrocare Electrosurgery SystemArthrocare Corp. · 1997
- 3 generations backK974521 Vnus Closure SystemVnus Medical Technologies, Inc. · 1998
- 2 generations backK982816 Vnus Closure SystemVnus Medical Technologies, Inc. · 1999
- 1 generation backK012398 Diomed 15 Diode LaserDiomed, Ltd. · 2002
- This deviceK070353 Kelsey Intersitital Laser Therapy SystemKelsey, Inc. · 2007
- Descendant · cites it directly · 0 of its ownK160392 Novilase Laser Therapy System, Model LTS-2Novian Health, Inc. · 2016
Most influential descendants
Showing 1 of 1 · See all- K160392Novilase Laser Therapy System, Model LTS-2Novian Health, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −7 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −6 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −5 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −4 | K971532 | Arthrocare Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −3 | K974521 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1998 | — |
| −2 | K982816 | Vnus Closure System | Vnus Medical Technologies, Inc. | 1999 | — |
| −1 | K012398 | Diomed 15 Diode Laser | Diomed, Ltd. | 2002 | — |
| 0 (this device) | K070353 | Kelsey Intersitital Laser Therapy System | Kelsey, Inc. | 2007 | — |
| +1 | K160392 | Novilase Laser Therapy System, Model LTS-2 | Novian Health, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 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? (4)
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 |
|---|---|---|---|
| * | K012398 | Diomed 15 Diode LaserSummary page 1…nstrument 3.5 Predicate Devices Diomed 15 Plus ................................................................................................................... K012398 Indigo 830 .................................................................................................................… | 2002 |
| * | K954195 | Indigo Portable Laser System, Inddigo FiberopticsSummary page 1…..................... K012398 Indigo 830 ........................................................................................................................... K954195 Indigo Diffuser Tip Fiberoptic w/Temp Sensing Option .................................................... K003953 Cryoc… | 1996 |
| * | K003953 | Indigo Diffuser-Tip Fiberoptic with Temperature Sensing Option, Model LF001Summary page 1….................................................. K954195 Indigo Diffuser Tip Fiberoptic w/Temp Sensing Option .................................................... K003953 CryocareTM Surgical System ............................................................................................... K… | 2001 |
| * | K003811 | Cryocare Surgical SystemSummary page 1…................................. K003953 CryocareTM Surgical System ............................................................................................... K003811 3.6 Device Description The Kelsey Interstitial Laser Therapy system consists of the following: * One laser probe, a 14… | 2001 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160392 | Novilase Laser Therapy System, Model LTS-2 | 2016 | 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 12 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 26 ancestors has a recall of any class.
- Of its descendants, K160392 (Novian Health, Inc., 2016) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K012398.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
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?
The Kelsey Interstitial Laser Therapy System is indicated for the treatment of fibroadenomas of the breast, with tumor sizes up to 20 mm; and for general surgery procedures including incision, excision and ablation of soft tissues; and coagulative necrosis and interstitial laser coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070353 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070353: Kelsey Intersitital Laser Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070353
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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