510(k) · Cleared
ClearedLightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity
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 Sep 18, 2017 as substantially equivalent to K053628 (Lumenis, Inc., 2006) and 2 other predicates after a 242-day review. Its family tree reaches back 11 generations to 1992. 14 later devices descend from it.
- Decided
- Sep 18, 2017
- Review
- 242 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K910422 (1992). 106 ancestors in all, the oldest K820106 (1982). 14 later devices descend from it, 7 citing it directly.
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations between
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
- This deviceK170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet…Lumenis, Ltd. · 2017
- Descendant · cites it directly · 8 of its ownK191321 Primelase ExcellenceHigh Technology Products S.L.U · 2019
- Descendant · cites it directly · 3 of its ownK192483 MeDioStarAsclepion Laser Technologies GmbH · 2020
- Descendant · cites it directly · 3 of its ownK193367 elysion-proHigh Technology Products S.L.U · 2020
- Descendant · cites it directly · 2 of its ownK201594 Primelase ExcellenceHigh Technology Products S.L.U · 2020
- Descendant · 2 generations on · 1 of its ownK241656 Eneka SelectifTermosalud · 2024
Show all 11 generations
- Root · 11 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 9 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 8 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 7 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 6 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 5 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 4 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 3 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 2 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 1 generation backK133319 ET Lightsheer 1060, High Speed Lightsheer 1060Lumenis, Ltd. · 2014
- This deviceK170179 LightSheer Desire; LightSheer Desire Light; LightSheer Duet…Lumenis, Ltd. · 2017
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K191321Primelase ExcellenceHigh Technology Products S.L.U · 2019 · cites it directly8descendants
- K192483MeDioStarAsclepion Laser Technologies GmbH · 2020 · cites it directly3descendants
- K193367elysion-proHigh Technology Products S.L.U · 2020 · cites it directly3descendants
- K201594Primelase ExcellenceHigh Technology Products S.L.U · 2020 · cites it directly2descendants
- K241656Eneka SelectifTermosalud · 2024 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −10 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −9 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −8 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −7 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −6 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −5 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −4 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −3 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −2 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −1 | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060 | Lumenis, Ltd. | 2014 | — |
| 0 (this device) | K170179 | LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity | Lumenis, Ltd. | 2017 | — |
| +1 | K191321 | Primelase Excellence | High Technology Products S.L.U | 2019 | — |
| +1 | K192483 | MeDioStar | Asclepion Laser Technologies GmbH | 2020 | — |
| +1 | K193367 | elysion-pro | High Technology Products S.L.U | 2020 | — |
| +1 | K201594 | Primelase Excellence | High Technology Products S.L.U | 2020 | — |
| +2 | K241656 | Eneka Selectif | Termosalud | 2024 | — |
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 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2026 | 2 | 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 6…duct Code: GEX Device Class: Class II Regulation Number: 21 CFR 878.4810 Panel: General & Plastic Surgery K053628 Lumenis LightSheer Duet Light Laser System Predicate Device: K151947 Lumenis LightSheer Desire Light Laser… | 2006 |
| * | K151947 | LightSheer Desire Light Laser SystemSummary page 6…4810 Panel: General & Plastic Surgery K053628 Lumenis LightSheer Duet Light Laser System Predicate Device: K151947 Lumenis LightSheer Desire Light Laser System K133319 LightSheer HS and ET 1060nm HPs for Duet === Page 7… | 2015 |
| * | K133319 | ET Lightsheer 1060, High Speed Lightsheer 1060Summary page 6…K053628 Lumenis LightSheer Duet Light Laser System Predicate Device: K151947 Lumenis LightSheer Desire Light Laser System K133319 LightSheer HS and ET 1060nm HPs for Duet Indications for Use: LightSheer Duet: The LightSheer Duet System is indi… | 2014 |
What descends from it? (14)
See all 147 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 25 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 4 of the 106 ancestors have a recall of any class.
- Of its descendants, K191321 (High Technology Products S.L.U, 2019) has gone furthest, with 8 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. 2017, 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?
LightSheer Duet: The LightSheer Duet System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Duet System is intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin. The LightSheer Duet System with LightSheer ET 805nm Laser Handpiece is intended for: • Treatment of benign vascular lesions, including angiomas…
Read the full statement (744 words)
LightSheer Duet:
The LightSheer Duet System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Duet System is intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.
The LightSheer Duet System with LightSheer ET 805nm Laser Handpiece is intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions
The LightSheer Duet System with LightSheer HS 805nm Laser Handpiece is intended for:
• Treatment of benign vascular lesions
• Treatment of benign pigmented lesions
• Hair removal, and permanent hair reduction*
LightSheer Desire:
The LightSheer Desire System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Desire System is intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.
The LightSheer Desire System with LightSheer ET/XC 805nm Laser Handpieces are intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions
The LightSheer Desire System with LightSheer HS 805nm Laser Handpiece is intended for:
• Treatment of benign vascular lesions
• Treatment of benign pigmented lesions
• Hair removal, and permanent hair reduction*
The LightSheer Desire System with LightSheer ET/XC 1060nm and LightSheer HS 1060nm Handpieces are intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions
• Hair removal, permanent hair reduction*
• Treatment for Pseudofolliculitis Barbae (PFB)
• Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
• Treatment of wrinkles
LightSheer Desire Light:
The LightSheer Desire Light System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Desire Light System is intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.
The LightSheer Desire Ligth System with LightSheer ET/XC 805nm Laser Handpieces are intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions
The LightSheer Desire Light System with LightSheer ET/XC 1060nm Handpiece is intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
• Hair removal, permanent hair reduction*
• Treatment for Pseudofolliculitis Barbae (PFB)
• Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
• Treatment of wrinkles
LightSheer Infinity:
The LightSheer Infinity System is indicated for use in surgical, aesthetic, and cosmetic applications in the medical specialties of general and plastic surgery, and dermatology. The LightSheer Infinity System is intended for use on all skin types (Fitzpatrick skin types I – VI), including tanned skin.
The LightSheer Infinity System with LightSheer ET/LR 805nm Laser Handpieces is intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia and other benign vascular lesions and leg veins
• Treatment of pseudofolliculitis barbae (PFB)
• Hair removal, permanent hair reduction*
• Treatment of benign pigmented lesions
The LightSheer Infinity System with LightSheer HS 805nm Laser Handpiece is intended for:
• Treatment of benign vascular lesions
• Treatment of benign pigmented lesions
• Hair removal, and permanent hair reduction*
The LightSheer Infinity System with LightSheer ET/LR 1060nm and LightSheer HS 1060nm Handpieces is intended for:
• Treatment of benign vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains, leg veins and other benign vascular lesions.
• Hair removal, permanent hair reduction
• Treatment for Pseudofolliculitis Barbae (PFB)
• Treatment of benign pigmented lesions, including age spots, solar lentigines, cafe-au-lait spots, nevi of Ota/Ito, melasma, Becker's nevi and other benign pigmented lesions
• Treatment of wrinkles
*Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170179 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170179: LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K170179
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