510(k) · Cleared
ClearedCandela Gentleyag Family of Laser Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corp. · GEX Powered Laser Surgical Instrument
Cleared on Oct 30, 2003 as substantially equivalent to K010104 (Candela Corp., 2001) and 8 other predicates after a 30-day review. Its family tree reaches back 7 generations to 1992. 654 later devices descend from it.
- Decided
- Oct 30, 2003
- Review
- 30 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 9
Its longest line of descent runs back 7 generations to K910422 (1992). 55 ancestors in all, the oldest K892514 (1990). 654 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 1 generation backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- This deviceK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · cites it directly · 316 of its ownK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- Descendant · 2 generations on · 284 of its ownK042319 Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 259 of its ownK061652 Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007
Showing 5 of 654 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 654 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K040617Reliant Laser System IIReliant Technologies, Inc. · 2004 · cites it directly316descendants
- K042319Reliant Laser II System and AccessoriesReliant Technologies, Inc. · 2005 · 2 generations on284descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007 · 3 generations on259descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −1 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| 0 (this device) | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +1 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| +2 | K042319 | Reliant Laser II System and Accessories | Reliant Technologies, Inc. | 2005 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K061652 | Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 6 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 15 | 0 |
| 2008 | 23 | 0 |
| 2009 | 14 | 0 |
| 2010 | 18 | 0 |
| 2011 | 20 | 0 |
| 2012 | 19 | 0 |
| 2013 | 23 | 0 |
| 2014 | 30 | 0 |
| 2015 | 24 | 0 |
| 2016 | 38 | 0 |
| 2017 | 30 | 0 |
| 2018 | 30 | 0 |
| 2019 | 22 | 0 |
| 2020 | 38 | 0 |
| 2021 | 31 | 0 |
| 2022 | 52 | 0 |
| 2023 | 40 | 0 |
| 2024 | 66 | 0 |
| 2025 | 69 | 0 |
| 2026 | 42 | 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? (9)
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 |
|---|---|---|---|
| * | K010104 | Candela Long Pulse ND:Yag | 2001 |
| * | K022923 | Candela Gentle Yag Laser SystemSummary page 2…entleYAG Laser Family of Laser Systems is equivalent to the Candela GentleYAG (aka Candela Long Pulse Nd: YAG Laser) cleared under KO10104, K022923,K022951,K023 193 the Lyra I ( K020021,K003765, KO03 147) and the Altus CoolGlide Family of Lasers (K023954,… | 2003 |
| * | K022951 | Candela Gentle Yag Laser System, Variable Pulse YagSummary page 2…Laser Family of Laser Systems is equivalent to the Candela GentleYAG (aka Candela Long Pulse Nd: YAG Laser) cleared under KO10104, K022923,K022951,K023 193 the Lyra I ( K020021,K003765, KO03 147) and the Altus CoolGlide Family of Lasers (K023954,… | 2003 |
| * | K023193 | Candela Gentle Yag Laser SystemSummary page 2…amily of Laser Systems is equivalent to the Candela GentleYAG (aka Candela Long Pulse Nd: YAG Laser) cleared under KO10104, K022923,K022951,K023 193 the Lyra I ( K020021,K003765, KO03 147) and the Altus CoolGlide Family of Lasers (K023954, KO 10834… | 2002 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…gy) 111. Predicate Devices Candela GentleYAG a.k.a Long Pulse Nd:YAG Laser (KO10104, K0022923. KO2295 1, KO23 193), Lyra I (K020021,K003765, KO03 147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765) IV. Product Descrip… | 2002 |
| * | K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…111. Predicate Devices Candela GentleYAG a.k.a Long Pulse Nd:YAG Laser (KO10104, K0022923. KO2295 1, KO23 193), Lyra I (K020021,K003765, KO03 147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765) IV. Product Description… | 2001 |
| * | K003147 | Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration) | 2000 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…a.k.a Long Pulse Nd:YAG Laser (KO10104, K0022923. KO2295 1, KO23 193), Lyra I (K020021,K003765, KO03 147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765) IV. Product Description The Candela GentleYAG Family of Laser Systems is a flash… | 2003 |
| * | K010834 | Lyra Series Surgical Laser System & AccessoriesSummary page 1…g Pulse Nd:YAG Laser (KO10104, K0022923. KO2295 1, KO23 193), Lyra I (K020021,K003765, KO03 147) Altus CoolGlide Family of Lasers (K023954, K010834,K003765) IV. Product Description The Candela GentleYAG Family of Laser Systems is a flashlamp-exci… | 2001 |
What descends from it? (654)
See all 65410 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042000 | Modified MSQ Family of Lovely Light/Laser Systems | 2004 | 517 |
| K040617 | Reliant Laser System II | 2004 | 316 |
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K050293 | Fotona XP Plus ND: Yag Family of Laser Systems, Fontona Dualis XP Plus ND: Yag Family of… | 2005 | 200 |
| K063074 | Candela 3630 Laser System | 2006 | 179 |
| K083889 | Fotona QX ND:Yag/KTP Laser System Family | 2009 | 166 |
| K090126 | Fotona XP ND: Yag Laser System Family, Fotona XP, XP-2 Focus, Fotona XP Changer,Model… | 2009 | 80 |
| K082039 | Synchro HP Platform | 2009 | 19 |
| K113115 | Epicare Yag | 2012 | 0 |
| K080697 | Skin Clear SRVH Long-Pulsed ND: Yag Laser | 2008 | 0 |
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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 55 ancestors has a recall of any class.
- Of its descendants, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.
- 5 other devices also cite its predicate K010104.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea,Venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as…
Read the full statement (167 words)
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. The lasers are indicted on all skin types Fitzpatrick I-VI including tanned skin.
Photocoagulation and hemostasis of pigmented and vascular lesions. such as but not limited to port wine stains, hemoangioma, warts, telangiectasia, rosacea,Venus lake, leg veins and spider veins.
Coagulation and hemostasis of soft tissue.
Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. The laser is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
Treatment of wrinkles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033172 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033172: Candela Gentleyag Family of Laser Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033172
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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