510(k) · Cleared
ClearedHarmonic Focus Shears
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ethicon Endo-Surgery, LLC · LFL Instrument, Ultrasonic Surgical
Cleared on Apr 7, 2010 as substantially equivalent to K063192 (Ethicon Endo-Surgery, LLC, 2007) and 7 other predicates after a 36-day review. Its family tree reaches back 12 generations to 1994. 18 later devices descend from it.
- Decided
- Apr 7, 2010
- Review
- 36 days
- Class
- Class U
- Product code
- LFL
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 12 generations to K936109 (1994). 82 ancestors in all, the oldest K800617 (1980). 18 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 8 generations between
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
- Descendant · cites it directly · 9 of its ownK133314 Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013
- Descendant · cites it directly · 6 of its ownK151743 THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016
- Descendant · 2 generations on · 4 of its ownK192103 Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020
- Descendant · 2 generations on · 4 of its ownK153371 Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016
- Descendant · 2 generations on · 3 of its ownK211838 Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · Recalled
Show all 12 generations
- Root · 12 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 11 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 10 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 9 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 8 generations backK990947 Modified Versapulse Select Single Wavelength, HO: Yag and Dual…Lumenis, Inc. · 1999
- 7 generations backK011703 Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength…Lumenis · 2001 · Recalled
- 6 generations backK014290 Entec Plasma WandsArthrocare Corp. · 2002
- 5 generations backK021364 Modification to Entec Plasma WandsArthrocare Corp. · 2002
- 4 generations backK030108 Arthrocare Ent Coblator Surgery SystemArthrocare Corp. · 2003 · Recalled
- 3 generations backK033257 Arthrocare Ent Plasma WandsArthrocare Corp. · 2003
- 2 generations backK063538 Arthrocare Controller (System 2000 and 8000), Arthrocare Patient…Arthrocare Corp. · 2006
- 1 generation backK070374 Arthrocare Ent Plasma WandArthrocare Corp. · 2007 · Recalled
- This deviceK100597 Harmonic Focus ShearsEthicon Endo-Surgery, LLC · 2010
Showing 5 of 18 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 18 · See all- K133314Harmonic Focus Shears + Adaptive Tissue TechnologyEthicon Endo-Surgery, LLC · 2013 · cites it directly9descendants
- K151743THUNDERBEAT Open Fine JawOlympus Medical Systems Corp. · 2016 · cites it directly6descendants
- K192103Thunderbeat Open Fine Jaw Type X Hand InstrumentOlympus Medical Systems Corp. · 2020 · 2 generations on4descendants
- K153371Sonicision Cordless Ultrasonic Dissection DeviceCovidien, LLC · 2016 · 2 generations on4descendants
- K211838Ultrasonic Bipolar Generator USG-410 with accessoriesOlympus Medical Systems Corporation · 2021 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −11 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −9 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −8 | K990947 | Modified Versapulse Select Single Wavelength, HO: Yag and Dual Wavelength, HO… | Lumenis, Inc. | 1999 | — |
| −7 | K011703 | Lumenis Versapulse Powersuite Holmium (HO:Yag) and Dual Wavelength… | Lumenis | 2001 | 2 |
| −6 | K014290 | Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −5 | K021364 | Modification to Entec Plasma Wands | Arthrocare Corp. | 2002 | — |
| −4 | K030108 | Arthrocare Ent Coblator Surgery System | Arthrocare Corp. | 2003 | 1 |
| −3 | K033257 | Arthrocare Ent Plasma Wands | Arthrocare Corp. | 2003 | — |
| −2 | K063538 | Arthrocare Controller (System 2000 and 8000), Arthrocare Patient Cable, Foot… | Arthrocare Corp. | 2006 | — |
| −1 | K070374 | Arthrocare Ent Plasma Wand | Arthrocare Corp. | 2007 | 1 |
| 0 (this device) | K100597 | Harmonic Focus Shears | Ethicon Endo-Surgery, LLC | 2010 | — |
| +1 | K133314 | Harmonic Focus Shears + Adaptive Tissue Technology | Ethicon Endo-Surgery, LLC | 2013 | — |
| +1 | K151743 | THUNDERBEAT Open Fine Jaw | Olympus Medical Systems Corp. | 2016 | — |
| +2 | K192103 | Thunderbeat Open Fine Jaw Type X Hand Instrument | Olympus Medical Systems Corp. | 2020 | — |
| +2 | K153371 | Sonicision Cordless Ultrasonic Dissection Device | Covidien, LLC | 2016 | — |
| +2 | K211838 | Ultrasonic Bipolar Generator USG-410 with accessories | Olympus Medical Systems Corporation | 2021 | 13 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 4 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 9 | 0 |
| 1996 | 10 | 0 |
| 1997 | 3 | 0 |
| 1998 | 8 | 0 |
| 1999 | 2 | 0 |
| 2000 | 6 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 LFL? 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 LFL device
- #1 K261448 neXus Ultrasonic Surgical Aspirator Systemscore 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (8)
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 |
|---|---|---|---|
| * | K063192 | Harmonic Focus Curved Shears and Torque Wrench, Harmonic Blue Hand Piece and Test TipSummary page 1…n Device [21 CFR 878.4400 (GEIILFL)] Device Class: Class 11 Predicate Devices: Harmonic FOCUSTM shears (K063 192) Harmonic Blades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgica… | 2007 |
| * | K060245 | Harmonic Scalpel Blades and ShearsSummary page 1…IILFL)] Device Class: Class 11 Predicate Devices: Harmonic FOCUSTM shears (K063 192) Harmonic Blades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgical System (1(031305) Conmed… | 2006 |
| * | K012176 | Ultracision Harmonic Scalpel Blades with Protective Sleeve, Models DH105, DH145, SH105…Summary page 1…Device Class: Class 11 Predicate Devices: Harmonic FOCUSTM shears (K063 192) Harmonic Blades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgical System (1(031305) Conmed Electrosur… | 2001 |
| * | K990362 | Instrument, Ultrasonic, ScalpelSummary page 1…Device Class: Class 11 Predicate Devices: Harmonic FOCUSTM shears (K063 192) Harmonic Blades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgical System (1(031305) Conmed Electrosurgical Pen… | 1999 |
| * | K031305 | Olympus Ultrasonic Surgical SystemSummary page 1…nic FOCUSTM shears (K063 192) Harmonic Blades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgical System (1(031305) Conmed Electrosurgical Pencils (K04 1868) ArthroCare ENT Coblator/Plasma… | 2003 |
| * | K041868 | Valupen,ProfileSummary page 1…lades (K(060245, 1(012176, K990362) Olympus Ultrasonic Surgical System (1(031305) Conmed Electrosurgical Pencils (K04 1868) ArthroCare ENT Coblator/Plasma Wands (K070374, K(030 108) Purpose of Submission: To modify thelIndi… | 2004 |
| * | K070374 | Arthrocare Ent Plasma WandSummary page 1…asonic Surgical System (1(031305) Conmed Electrosurgical Pencils (K04 1868) ArthroCare ENT Coblator/Plasma Wands (K070374, K(030 108) Purpose of Submission: To modify thelIndications for Use Statement to include the specific indication to use the dev… | 2007 |
| * | K030108 | Arthrocare Ent Coblator Surgery System | 2003 |
What descends from it? (18)
See all 183 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 16 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 82 ancestors have a recall of any class.
- Of its descendants, K133314 (Ethicon Endo-Surgery, LLC, 2013) has gone furthest, with 9 descendants of its own.
- 4 other devices also cite its predicate K063192.
How does its category compare?
All LFL devicesLFL Instrument, Ultrasonic Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · LFL
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LFL
176in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LFL
11in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LFL
3,857in 2025
MAUDE reports naming product code LFL, 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 | 7 | 99 | 0 | 2,236 |
| 2008 | 2 | — | 0 | 1,678 |
| 2009 | 1 | — | 0 | 3,324 |
| 2010 | 2 | — | 3 | 1,239 |
| 2011 | 3 | 241 | 2 | 1,053 |
| 2012 | 3 | 82 | 5 | 1,491 |
| 2013 | 5 | 73 | 0 | 2,430 |
| 2014 | 3 | 136 | 1 | 4,260 |
| 2015 | 4 | 99 | 1 | 2,777 |
| 2016 | 5 | 111 | 0 | 2,691 |
| 2017 | 2 | — | 1 | 3,267 |
| 2018 | 3 | 66 | 0 | 3,461 |
| 2019 | 4 | 103 | 42 | 3,153 |
| 2020 | 4 | 190 | 0 | 2,934 |
| 2021 | 6 | 83 | 1 | 3,289 |
| 2022 | 8 | 168 | 0 | 3,422 |
| 2023 | 4 | 104 | 2 | 4,215 |
| 2024 | 3 | 158 | 11 | 4,017 |
| 2025 | 3 | 176 | 0 | 3,857 |
| 2026 | 3 | 99 | 1 | — |
What is it indicated for?
The HARMONIC FOCUS Shears are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, otorhinolaryngologic (ENT), plastic, pediatric, gynecologic, urologic, exposure to orthopedic structures (such as spine and joint space), and other open procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100597: Harmonic Focus Shears.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100597
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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