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 Jul 13, 1998 as substantially equivalent to K974381 (Candela Corp., 1998) and 3 other predicates after a 90-day review. Its family tree reaches back 3 generations to 1996. 811 later devices descend from it.
- Decided
- Jul 13, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K963094 (1996). 5 ancestors in all. 811 later devices descend from it, 5 citing it directly.
- Root · 3 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 2 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 1 generation backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- This deviceK981351 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- Descendant · cites it directly · 745 of its ownK991798 Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000
- Descendant · 2 generations on · 739 of its ownK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- Descendant · 2 generations on · 665 of its ownK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- Descendant · 3 generations on · 656 of its ownK022923 Candela Gentle Yag Laser SystemCandela Corp. · 2003
- Descendant · 3 generations on · 656 of its ownK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
Showing 5 of 811 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 811 · See all- K991798Acme Medical Aesthetic ND:Yag LaserAltus Medical · 2000 · cites it directly745descendants
- K014040Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and…Altus Medical, Inc. · 2002 · 2 generations on739descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
- K022923Candela Gentle Yag Laser SystemCandela Corp. · 2003 · 3 generations on656descendants
- K023193Candela Gentle Yag Laser SystemCandela Corp. · 2002 · 3 generations on656descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −2 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −1 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| 0 (this device) | K981351 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| +1 | K991798 | Acme Medical Aesthetic ND:Yag Laser | Altus Medical | 2000 | — |
| +2 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| +2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +3 | K022923 | Candela Gentle Yag Laser System | Candela Corp. | 2003 | — |
| +3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 4 | 0 |
| 2002 | 8 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 7 | 0 |
| 2006 | 9 | 0 |
| 2007 | 18 | 0 |
| 2008 | 28 | 0 |
| 2009 | 20 | 0 |
| 2010 | 19 | 0 |
| 2011 | 26 | 0 |
| 2012 | 23 | 0 |
| 2013 | 29 | 0 |
| 2014 | 33 | 0 |
| 2015 | 32 | 0 |
| 2016 | 42 | 0 |
| 2017 | 37 | 0 |
| 2018 | 35 | 0 |
| 2019 | 27 | 0 |
| 2020 | 44 | 0 |
| 2021 | 34 | 0 |
| 2022 | 60 | 0 |
| 2023 | 45 | 0 |
| 2024 | 75 | 0 |
| 2025 | 85 | 0 |
| 2026 | 49 | 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? (4)
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, Cynosure Photogenica LP Laser cleared under 510(k) notification numbers K963094 and K971737 and the Sharplan Model 5000 Laser c… | 1998 |
| * | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion LaserSummary page 1…e Alexandrite Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k) 974381, Cynosure Photogenica LP Laser cleared under 510(k) notification numbers K963094 and K971737 and the Sharplan Model 5000 Laser cleared under 510(k) number 971784 Description: The Candela (Modified) GentleLase… | 1996 |
| * | K971737 | Cynosure Photogenica Lpir Dermatological LaserSummary page 1…e Laser Predicate Devices: Candela GentleLase GL laser cleared under 510(k) 974381, Cynosure Photogenica LP Laser cleared under 510(k) notification numbers K963094 and K971737 and the Sharplan Model 5000 Laser cleared under 510(k) number 971784 Description: The Candela (Modified) GentleLase GL Laser ut… | 1997 |
| * | K971874 | Sharplan Epitouch Alexandrite Laser System (5000) Our OCR of the scanned summary read K971784, FDA’s number for Zeus Scientific, Inc., Anticardiolipin Igg/Igm Elisa Test… (Zeus Scientific, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Sharplan Model 5000 Laser”. | 1997 |
What descends from it? (811)
See all 8115 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 2 years and passes through 2 companies; a new generation was cleared every 5 months on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K991798 (Altus Medical, 2000) has gone furthest, with 745 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. the removal of hair.
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/K981351 · printed Nov 6, 2026
Cite this page
510(k) Report. “K981351: Candela Gentlelase GL Dermatological Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K981351
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