510(k) · Cleared
ClearedCandela Sclero Long Pulse Dye 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 Jan 24, 2000 as substantially equivalent to K954934 (Candela Laser Corp., 1996) and 6 other predicates after an 84-day review. Its family tree reaches back 3 generations to 1991. 700 later devices descend from it.
- Decided
- Jan 24, 2000
- Review
- 84 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K904627 (1991). 27 ancestors in all, the oldest K882160 (1988). 700 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK904627 Centauri Yag Laser Syst, Ear, Nose , ThroatPfizer Laser Systems · 1991
- 2 generations backK960032 Coherent Versapulse Aesthetic Surgical LasersCoherent Medical Group · 1996
- 1 generation backK972347 Modified Coherent Versapulse Aesthetic Surgical LaserLumenis, Inc. · 1997
- This deviceK993671 Candela Sclero Long Pulse Dye LaserCandela Corp. · 2000
- Descendant · cites it directly · 699 of its ownK013748 Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 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 · 519 of its ownK033251 The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004
- Descendant · 4 generations on · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 318 of its ownK021180 Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002
Showing 5 of 700 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 700 · See all- K013748Candela Sclero Long Pulse Laser (Aka Vbeam)Candela Corp. · 2002 · cites it directly699descendants
- K022226Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Altus Medical, Inc. · 2002 · 2 generations on665descendants
- K033251The Friendlylight ND: Yag LasersInnotech USA, Inc. · 2004 · 3 generations on519descendants
- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · 4 generations on517descendants
- K021180Candela Vbeam Pulsed Dye Laser SystemCandela Corp. · 2002 · 2 generations on318descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904627 | Centauri Yag Laser Syst, Ear, Nose , Throat | Pfizer Laser Systems | 1991 | — |
| −2 | K960032 | Coherent Versapulse Aesthetic Surgical Lasers | Coherent Medical Group | 1996 | — |
| −1 | K972347 | Modified Coherent Versapulse Aesthetic Surgical Laser | Lumenis, Inc. | 1997 | — |
| 0 (this device) | K993671 | Candela Sclero Long Pulse Dye Laser | Candela Corp. | 2000 | — |
| +1 | K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | Candela Corp. | 2002 | — |
| +2 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| +3 | K033251 | The Friendlylight ND: Yag Lasers | Innotech USA, Inc. | 2004 | — |
| +4 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K021180 | Candela Vbeam Pulsed Dye Laser System | Candela Corp. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1991 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 8 | 0 |
| 1995 | 4 | 0 |
| 1996 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 7 | 0 |
| 2005 | 6 | 0 |
| 2006 | 5 | 0 |
| 2007 | 12 | 0 |
| 2008 | 24 | 0 |
| 2009 | 12 | 0 |
| 2010 | 18 | 0 |
| 2011 | 23 | 0 |
| 2012 | 20 | 0 |
| 2013 | 24 | 0 |
| 2014 | 29 | 0 |
| 2015 | 27 | 0 |
| 2016 | 38 | 0 |
| 2017 | 31 | 0 |
| 2018 | 32 | 0 |
| 2019 | 21 | 0 |
| 2020 | 41 | 0 |
| 2021 | 31 | 0 |
| 2022 | 52 | 0 |
| 2023 | 41 | 0 |
| 2024 | 70 | 0 |
| 2025 | 82 | 0 |
| 2026 | 46 | 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? (7)
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 |
|---|---|---|---|
| * | K954934 | Candela SPTL Long Pulse/Tunable Pulsed Dye LaseSummary page 1…Dermatology) Common Name: Dermatology Laser, Long Pulse Dye Laser System Predicate Devices: Candela SPTL Long Pulse/Tunable Pulse Dye Laser cleared under 510(k) number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K9723… | 1996 |
| * | K931762 | Candela SPTL Pulsed Dye LasersSummary page 1…me: Dermatology Laser, Long Pulse Dye Laser System Predicate Devices: Candela SPTL Long Pulse/Tunable Pulse Dye Laser cleared under 510(k) number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Me… | 1994 |
| * | K882160 | Coherent System 920 Argon/Dye PhotocoagulatorSummary page 1…e Laser System Predicate Devices: Candela SPTL Long Pulse/Tunable Pulse Dye Laser cleared under 510(k) number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Medicine and Diagnostics Spectrum Vein… | 1988 |
| * | K971737 | Cynosure Photogenica Lpir Dermatological LaserSummary page 1…andela SPTL Long Pulse/Tunable Pulse Dye Laser cleared under 510(k) number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Medicine and Diagnostics Spectrum VeinLase (K981952), and Altus CoolGlide… | 1997 |
| * | K972347 | Modified Coherent Versapulse Aesthetic Surgical LaserSummary page 1…Dye Laser cleared under 510(k) number K954934, Candela SPTL (K931762), Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Medicine and Diagnostics Spectrum VeinLase (K981952), and Altus CoolGlide (K991234) Description: The Sclero LP… | 1997 |
| * | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green LaserSummary page 1…Coherent Argon/Dye Laser (K882160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Medicine and Diagnostics Spectrum VeinLase (K981952), and Altus CoolGlide (K991234) Description: The Sclero LP laser is a pulsed, flash lamp excited dye, medical laser, controlled… | 1998 |
| * | K991234 | The Acme Medical Aesthetic ND:Yag LaserSummary page 1…160), Cynosure LPIR, Apogee 40 (K971737), Coherent VersaPulse Laser (K972347), Instruments for Medicine and Diagnostics Spectrum VeinLase (K981952), and Altus CoolGlide (K991234) Description: The Sclero LP laser is a pulsed, flash lamp excited dye, medical laser, controlled by an embedded processor, to b… | 1999 |
What descends from it? (700)
See all 7001 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013748 | Candela Sclero Long Pulse Laser (Aka Vbeam) | 2002 | 699 |
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 9 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- None of the 27 ancestors has a recall.
- Of its descendants, K013748 (Candela Corp., 2002) has gone furthest, with 699 descendants of its own.
- 1 other device also cites its predicate K954934.
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 Sclero Long Pulse Laser is indicated for the following uses: General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions. Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma;, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae. Gynecology…
Read the full statement (110 words)
The Candela Sclero Long Pulse Laser is indicated for the following uses:
General Surgery: Photocoagulation of benign cutaneous vascular lesion and benign cutaneous lesions.
Dermatology/Plastic Surgery: For treatment of benign cutaneous vascular lesion, such as facial and leg telangiectasia, rosacea, port wine stains, hemangiomas, angioma;, spider angioma, poikiloderma of Civatte and benign cutaneous lesion, such as warts, scars, striae.
Gynecology: Photocoagulation of benign cutaneous lesion and benign vascular lesion in gynecology
Podiatry: Treatment of benign cutaneous lesion, such as warts.
The Candela Sclero Long Pulse Laser includes an integrated Dynamic Cooling Device, which is indicated for:
1. the reduction in pain.
2. cooling of the skin prior to laser treatment
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/K993671 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993671: Candela Sclero Long Pulse Dye Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993671
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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