510(k) · Cleared
ClearedCutera ER:Ysgg Laser Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 27, 2007 as substantially equivalent to K060033 (Sciton, Inc, 2006) and 3 other predicates after an 88-day review. Its family tree reaches back 10 generations to 1992. 2 later devices descend from it.
- Decided
- Mar 27, 2007
- Review
- 88 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 10 generations to K910422 (1992). 242 ancestors in all, the oldest K771218 (1978). 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
- Descendant · cites it directly · 1 of its ownK080530 Modification to Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2008
- Descendant · 2 generations on · 0 of its ownK210183 Waterlase iPLusBiolase, Inc. · 2022
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 4 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 3 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 2 generations backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- 1 generation backK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- This deviceK063867 Cutera ER:Ysgg Laser HandpieceCutera, Inc. · 2007
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −4 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −3 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −2 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| −1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| 0 (this device) | K063867 | Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2007 | — |
| +1 | K080530 | Modification to Cutera ER:Ysgg Laser Handpiece | Cutera, Inc. | 2008 | — |
| +2 | K210183 | Waterlase iPLus | Biolase, Inc. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 11 | 0 |
| 1994 | 15 | 0 |
| 1995 | 13 | 0 |
| 1996 | 14 | 0 |
| 1997 | 19 | 0 |
| 1998 | 20 | 0 |
| 1999 | 15 | 0 |
| 2000 | 20 | 0 |
| 2001 | 24 | 0 |
| 2002 | 27 | 0 |
| 2003 | 20 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K060033 | Profile Multi-Platform SystemSummary page 1…pthalmic Laser, HQF Common Name: Dermatology Laser Opthalmic Laser !II. Predicate Devices * K060033 Sciton Profile Er:YAG * K062354 BioLase Oculase MD * K032599… | 2006 |
| * | K052354 | Oculase MD Our reading of the summary gave K062354, FDA’s number for Vectra Genisys VMS FR (Encore Medical L.P.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “BioLase Oculase MD”. | 2006 |
| * | K032599 | Medical Laser Technologies, LLC MTL Erbium:Yag Laser SystemSummary page 1…thalmic Laser !II. Predicate Devices * K060033 Sciton Profile Er:YAG * K062354 BioLase Oculase MD * K032599 MLT Erbium:YAG * K031140 BioLase Waterlase IV. Product Description/Technologica… | 2003 |
| * | K031140 | WaterlaseSummary page 1…K060033 Sciton Profile Er:YAG * K062354 BioLase Oculase MD * K032599 MLT Erbium:YAG * K031140 BioLase Waterlase IV. Product Description/Technological Characteristics The Cutera Er:YSGG Laser ha… | 2004 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080530 | Modification to Cutera ER:Ysgg Laser Handpiece | 2008 | 1 |
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 15 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 12 of the 242 ancestors have a recall of any class.
- Of its descendants, K080530 (Cutera, Inc., 2008) has gone furthest, with 1 descendant of its own.
- 8 other devices also cite its predicate K060033.
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 Cutera Er:YSGG Laser Handpiece is designed for use in applications requiring the excision, incision, ablation, vaporization and coagulation of soft tissue.
Dermatology and Plastic Surgery
Indications include: treatment of wrinkles and skin resurfacing.
Opthalmology
Indications include: Incision, excision, vaporization and coagulation of tissue surrounding the eye and orbit.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063867 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063867: Cutera ER:Ysgg Laser Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063867
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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