510(k) · Cleared
Recalled · Class II · 2017PhotonBlade
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Invuity, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Sep 15, 2016 as substantially equivalent to K093695 (Peak Surgical, Inc., 2010) and 1 other predicate after a 52-day review. Its family tree reaches back 5 generations to 1994. 1 later device descends from it. It has been recalled once.
- Decided
- Sep 15, 2016
- Review
- 52 days
- Class
- Class II
- Product code
- GEI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K933157 (1994). 22 ancestors in all, the oldest K780977 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK933157 Erbotom Icc 200Erbe USA, Inc. · 1994
- 4 generations backK013255 Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RFEllman Intl., Inc. · 2001
- 3 generations backK061174 Surgi-MaxEllman Int'L, Inc. · 2006
- 2 generations backK082786 Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue…Peak Surgical, Inc. · 2008 · Recalled
- 1 generation backK093695 Peak Plasmablade 3.OS Tissue Dissection DevicePeak Surgical, Inc. · 2010
- This deviceK162053 PhotonBladeInvuity, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK191583 PhotonBlade with Smoke EvacuationInvuity, Inc. · 2020
Most influential descendants
Showing 1 of 1 · See all- K191583PhotonBlade with Smoke EvacuationInvuity, Inc. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K933157 | Erbotom Icc 200 | Erbe USA, Inc. | 1994 | — |
| −4 | K013255 | Surgitron 120 Iec (Also Known as Surgitron 4.0 Dual RF | Ellman Intl., Inc. | 2001 | — |
| −3 | K061174 | Surgi-Max | Ellman Int'L, Inc. | 2006 | — |
| −2 | K082786 | Pulsar Generator, Peak Plasmablade; 4.0, Needle, and Ext Tissue Dissection… | Peak Surgical, Inc. | 2008 | 1 |
| −1 | K093695 | Peak Plasmablade 3.OS Tissue Dissection Device | Peak Surgical, Inc. | 2010 | — |
| 0 (this device) | K162053 | PhotonBlade | Invuity, Inc. | 2016 | — |
| +1 | K191583 | PhotonBlade with Smoke Evacuation | Invuity, Inc. | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1979 | 1 | 0 |
| 1991 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K093695 | Peak Plasmablade 3.OS Tissue Dissection DeviceSummary page 4…Panel: General and Plastic Surgery Device Classification: Class 11 5.5 Predicate device(s): • PEAK Surgical PlasmaBlade 3.0S (K093695) • PARE NOVA ES Pencil with Surgical Light Source (K944363) 5.6 Device description The PhotonBlade… | 2010 |
| * | K944363 | Model PBD Esu PencilSummary page 4…ication: Class 11 5.5 Predicate device(s): • PEAK Surgical PlasmaBlade 3.0S (K093695) • PARE NOVA ES Pencil with Surgical Light Source (K944363) 5.6 Device description The PhotonBlade is a single use, sterile, electrosurgical device with a light.… | 1994 |
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 |
|---|---|---|---|
| K191583 | PhotonBlade with Smoke Evacuation | 2020 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 12, 2017 | Class II | Z-2778-2017 | Device Design | A small number of customer observations were recently received which related to possible unintended energy discharge with the potential to cause tissue damage to patients. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 5 companies; a new generation was cleared every 4.6 years on median.
- 5 of the 22 ancestors have a recall of any class.
- Of its descendants, K191583 (Invuity, Inc., 2020) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K093695.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The PhotonBlade is a monopolar RF device coupled with illumination that is indicated for cutting and coagulation of
tissue during general surgical procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162053 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162053: PhotonBlade.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162053
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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