510(k) · Cleared
ClearedCandela Gentlelase GL Dermatological Laser
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 May 26, 2000 as substantially equivalent to K974381 (Candela Corp., 1998) and 4 other predicates after a 161-day review. Its family tree reaches back 4 generations to 1996. 258 later devices descend from it.
- Decided
- May 26, 2000
- Review
- 161 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 4 generations to K963094 (1996). 13 ancestors in all, the oldest K950019 (1995). 258 later devices descend from it, 11 citing it directly.
- Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 3 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 2 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 1 generation backK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- This deviceK994260 Candela Gentlelase GL Dermatological LaserCandela Corp. · 2000
- Descendant · cites it directly · 207 of its ownK024371 Candela Gentle Lase Family of Laser SystemCandela Corp. · 2003
- Descendant · cites it directly · 187 of its ownK024335 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
- Descendant · cites it directly · 186 of its ownK024260 Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · Recalled
- Descendant · 2 generations on · 179 of its ownK063074 Candela 3630 Laser SystemCandela Corp. · 2006
- Descendant · 2 generations on · 136 of its ownK043251 Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam…Candela Corp. · 2005
Showing 5 of 258 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 258 · See all- K024371Candela Gentle Lase Family of Laser SystemCandela Corp. · 2003 · cites it directly207descendants
- K024335Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · cites it directly187descendants
- K024260Candela Gentlelase Family of Laser SystemsCandela Corp. · 2003 · cites it directly186descendants
- K063074Candela 3630 Laser SystemCandela Corp. · 2006 · 2 generations on179descendants
- K043251Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1BCandela Corp. · 2005 · 2 generations on136descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −3 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −2 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −1 | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| 0 (this device) | K994260 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 2000 | — |
| +1 | K024371 | Candela Gentle Lase Family of Laser System | Candela Corp. | 2003 | — |
| +1 | K024335 | Candela Gentlelase Family of Laser Systems | Candela Corp. | 2003 | 1 |
| +1 | K024260 | Candela Gentlelase Family of Laser Systems | Candela Corp. | 2003 | 1 |
| +2 | K063074 | Candela 3630 Laser System | Candela Corp. | 2006 | — |
| +2 | K043251 | Candela Family of Pulsed Dye Laser Systems, Models Vbeam, Cbeam, SPTL-1B | Candela Corp. | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 10 | 0 |
| 2009 | 4 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 6 | 0 |
| 2014 | 7 | 0 |
| 2015 | 10 | 0 |
| 2016 | 9 | 0 |
| 2017 | 10 | 0 |
| 2018 | 17 | 0 |
| 2019 | 10 | 0 |
| 2020 | 19 | 0 |
| 2021 | 12 | 0 |
| 2022 | 27 | 0 |
| 2023 | 16 | 0 |
| 2024 | 25 | 0 |
| 2025 | 31 | 0 |
| 2026 | 19 | 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? (5)
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 |
|---|---|---|---|
| * | K974381 | Candela Gentlelase GL Dermatological LaserSummary page 1…nd Plastic Surgery and in Dermatology) Common Name: Dermatology Laser, Long pulse Alexandrite Laser Predicate Devices: Candela GentleLASE GL laser cleared under 510(k) 974381, cleared on February 10, 1998. The hair count reduction indication as included in 510(k) K981351, was cleared on July 13, 1998.… | 1998 |
| * | K981351 | Candela Gentlelase GL Dermatological LaserSummary page 1…ser Predicate Devices: Candela GentleLASE GL laser cleared under 510(k) 974381, cleared on February 10, 1998. The hair count reduction indication as included in 510(k) K981351, was cleared on July 13, 1998. The Star Medical Technologies, Inc. LightSheer™ Laser, which was cleared for the indication of per… | 1998 |
| * | K982940 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…was cleared on July 13, 1998. The Star Medical Technologies, Inc. LightSheer™ Laser, which was cleared for the indication of permanent hair reduction under 510(k) number K982940. The Palomar Medical Technologies, Inc. EpiLaser®, was cleared for the indication of permanent hair reduction under 510(k) number… | 1999 |
| * | K980517 | Epilaser Normal Mode Ruby LaserSummary page 1…r reduction under 510(k) number K982940. The Palomar Medical Technologies, Inc. EpiLaser®, was cleared for the indication of permanent hair reduction under 510(k) number K980517. The Laserscope Lyra™ Laser System, was cleared for treatment of vascular lesions under 510(k) number K990903. Description: The… | 1998 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…indication of permanent hair reduction under 510(k) number K980517. The Laserscope Lyra™ Laser System, was cleared for treatment of vascular lesions under 510(k) number K990903. Description: The Candela (Modified) GentleLASE GL Laser utilizes an Alexandrite rod (crystal) which emits pulsed energy at 755… | 1999 |
What descends from it? (258)
See all 25811 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K024371 | Candela Gentle Lase Family of Laser System | 2003 | 207 |
| K024335 | Candela Gentlelase Family of Laser Systems | 2003 | 187 |
| K024260 | Candela Gentlelase Family of Laser Systems | 2003 | 186 |
| K042474 | ARION | 2004 | 114 |
| K020412 | Depilase Twin Lase Laser System | 2002 | 106 |
| K032218 | Adept 1064/532/755 Laser | 2003 | 104 |
| K111144 | Candela Gentlelase Family of Lasers | 2011 | 91 |
| K051876 | Multiwave XR | 2005 | 0 |
| K041262 | Duralite-GL | 2004 | 0 |
| K032221 | Adept 1064/755 Laser | 2003 | 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 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- 1 of the 13 ancestors has a recall of any class.
- Of its descendants, K024371 (Candela Corp., 2003) has gone furthest, with 207 descendants of its own.
- 4 other devices also cite its predicate K974381.
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?
The Candela GentleLASE GL Dermatology Laser is indicated for the following uses:
1. The Photocoagulation of Dermatological vascular lesions.
2. Temporary hair reduction.
3. Stable long-term, or permanent hair reduction through selective targetlng 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. It is also intended for the photocoagulation of dermatological vascular lesions.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994260 · printed Nov 4, 2026
Cite this page
510(k) Report. “K994260: Candela Gentlelase GL Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K994260
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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