510(k) · Cleared
ClearedGentleMax Pro Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Candela Corporation · GEX Powered Laser Surgical Instrument
Cleared on May 26, 2020 as substantially equivalent to K140122 (Candela Corp., 2014) after a 29-day review. Its family tree reaches back 12 generations to 1992. 3 later devices descend from it.
- Decided
- May 26, 2020
- Review
- 29 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K910422 (1992). 139 ancestors in all, the oldest K820106 (1982). 3 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 2 generations backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- 1 generation backK140122 Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
- This deviceK201111 GentleMax Pro PlusCandela Corporation · 2020
- Descendant · cites it directly · 0 of its ownK252877 SANDRO DualWontech Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK223540 AvalancheLase FamilyFotona D.O.O. · 2023
- Descendant · cites it directly · 0 of its ownK222673 Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser) · 2022
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- 3 generations backK112715 Candela Gentlemax Family of LasersCandela Corp. · 2011
- 2 generations backK133283 Candela Gentlemax Family of Laser SystemsCandela Corp. · 2013
- 1 generation backK140122 Candela Gentlemax Family of Laser SystemCandela Corp. · 2014
- This deviceK201111 GentleMax Pro PlusCandela Corporation · 2020
Most influential descendants
Showing 3 of 3 · See all- K252877SANDRO DualWontech Co., Ltd. · 2025 · cites it directly0descendants
- K223540AvalancheLase FamilyFotona D.O.O. · 2023 · cites it directly0descendants
- K222673Alexandrite and Nd:YAG Laser models CANLASE and TORLASECanadian Pioneer Medical Technology Corporation (Cpmt Laser) · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| −3 | K112715 | Candela Gentlemax Family of Lasers | Candela Corp. | 2011 | — |
| −2 | K133283 | Candela Gentlemax Family of Laser Systems | Candela Corp. | 2013 | — |
| −1 | K140122 | Candela Gentlemax Family of Laser System | Candela Corp. | 2014 | — |
| 0 (this device) | K201111 | GentleMax Pro Plus | Candela Corporation | 2020 | — |
| +1 | K252877 | SANDRO Dual | Wontech Co., Ltd. | 2025 | — |
| +1 | K223540 | AvalancheLase Family | Fotona D.O.O. | 2023 | — |
| +1 | K222673 | Alexandrite and Nd:YAG Laser models CANLASE and TORLASE | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 6 | 0 |
| 1994 | 12 | 0 |
| 1995 | 8 | 0 |
| 1996 | 11 | 0 |
| 1997 | 11 | 0 |
| 1998 | 10 | 0 |
| 1999 | 6 | 0 |
| 2000 | 11 | 0 |
| 2001 | 12 | 0 |
| 2002 | 12 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2025 | 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? (1)
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 |
|---|---|---|---|
| * | K140122 | Candela Gentlemax Family of Laser SystemSummary page 5…EX Device Classification: Class II Laser Classification: Class IV 5. PREDICATE DEVICE Candela GentleMAX Family of Lasers System (K140122). Candela Corporation GentleMax Pro Plus Laser System K201111… | 2014 |
What descends from it? (3)
3 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 28 years and passes through 6 companies; a new generation was cleared every 2.2 years on median.
- 5 of the 139 ancestors have a recall of any class.
- Of its descendants, K252877 (Wontech Co., Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K140122.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, 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?
755nm: Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types…
Read the full statement (311 words)
755nm:
Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin.
Treatment of benign pigmented lesions.
Treatment of wrinkles.
The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).
1064nm:
Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of 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. The lasers are indicated 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, hemangioma, 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 keratosis, nevi, chloasma, verrucae, skin tags, keratosis, 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.
Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.
Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K201111 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201111: GentleMax Pro Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201111
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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