510(k) · Cleared
ClearedET Lightsheer 1060, High Speed Lightsheer 1060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumenis, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Mar 20, 2014 as substantially equivalent to K053628 (Lumenis, Inc., 2006) and 2 other predicates after a 143-day review. Its family tree reaches back 10 generations to 1992. 24 later devices descend from it.
- Decided
- Mar 20, 2014
- Review
- 143 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 10 generations to K910422 (1992). 104 ancestors in all, the oldest K820106 (1982). 24 later devices descend from it, 4 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 backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
- Descendant · cites it directly · 14 of its ownK170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet…Lumenis, Ltd. · 2017
- Descendant · cites it directly · 14 of its ownK141555 AdvantageLutronic Corporation · 2014
- Descendant · 2 generations on · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · 2 generations on · 3 of its ownK192483 MeDioStarAsclepion Laser Technologies GmbH · 2020
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 backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 1 generation backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- This deviceK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
Showing 5 of 24 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 24 · See all- K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityLumenis, Ltd. · 2017 · cites it directly14descendants
- K141555AdvantageLutronic Corporation · 2014 · cites it directly14descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 2 generations on13descendants
- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · 2 generations on8descendants
- K192483MeDioStarAsclepion Laser Technologies GmbH · 2020 · 2 generations on3descendants
View 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 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −1 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| 0 (this device) | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060 | Lumenis, Ltd. | 2014 | — |
| +1 | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Lumenis, Ltd. | 2017 | — |
| +1 | K141555 | Advantage | Lutronic Corporation | 2014 | — |
| +2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +2 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +2 | K192483 | MeDioStar | Asclepion Laser Technologies GmbH | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 8 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 10 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 4 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K053628 | Lightsheer Duet Laser SystemSummary page 2…33319 Ehancing Life. Advancing Technology. Predicate Devices: LightSheer Duet Laser System from Lumenis Ltd, cleared under 5 10(k) K053628, the Family of Altus Medical CoolGlide Aesthetic Lasers from Altus Medical, Inc.… | 2006 |
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 3…characteristics as the Family of Altus Medical CoolGlide Aesthetic Lasers from Altus Medical, Inc. (currently Cutera Inc.) cleared under 5 10(k) K022226 and the GentleMAX Family of Laser Systems from Candela Corporation cleared under 510(k) KI 12715. Testing… | 2002 |
| * | K112715 | Candela Gentlemax Family of LasersSummary page 2…N 022226, and the GentleMAX Family of (currently Cutera Inc.) cleared under 5 1(k Laser Systems from Candela Corporation cleared under 5 10(k) KI112715. Description of the device: The ET LightSheer 1060 and High Speed LightSheer 1060 are two treatment handpie… | 2011 |
What descends from it? (24)
See all 244 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 22 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 104 ancestors have a recall of any class.
- Of its descendants, K170179 (Lumenis, Ltd., 2017) has gone furthest, with 14 descendants of its own.
- 8 other devices also cite its predicate K053628.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas. lelangiectasia, part wine stains, leg veins and other benign vascular lesions. ET LightSheeir 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbee (PFB ). Permanent hair reduction is defined as the long-term, stable reduction in the number…
Read the full statement (157 words)
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for treatment of vascular lesions, including angiomas, hemangiomas. lelangiectasia, part wine stains, leg veins and other benign vascular lesions.
ET LightSheeir 1060 and High Speed LightSheer 1060 are intended for hair removal, permanent hair reduction, and the treatment for Pseudofolliculitis Barbee (PFB ).
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for the treatment of benign pigmcnted lesions, including age spots, solar lentigines, cafd-au-lait spots, nevi of OteA/to, melasma, Becker's nevi and other benign pigmented lesions.
ET LightSheer 1060 and High Speed LightSheer 1060 are also intended for treatment of wrinkles.
ET LightSheer 1060 and High Speed LightSheer 1060 are intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133319 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133319: ET Lightsheer 1060, High Speed Lightsheer 1060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133319
Report an extraction error
Are you the manufacturer?
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