510(k) · Cleared
ClearedProfile 1320 Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sciton, Inc · GEX Powered Laser Surgical Instrument
Cleared on Mar 9, 2004 as substantially equivalent to K022466 (Sciton, Inc, 2002) and 9 other predicates after a 211-day review. Its family tree reaches back 4 generations to 1982. 518 later devices descend from it.
- Decided
- Mar 9, 2004
- Review
- 211 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 10
Its longest line of descent runs back 4 generations to K820106 (1982). 20 ancestors in all. 518 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK820106 X-Ray Guaze SpongesStan-Pak Ent. · 1982
- 3 generations backK962791 New Star Model 130 6-Watt ND: Yag Laser SystemNew Star Lasers, Inc. · 1997
- 2 generations backK014035 Cooltouch and Cooltouch-II ND:Yag Laser SystemsCooltouch Corp. · 2002
- 1 generation backK022466 Profile 1320 Laser SystemSciton, Inc · 2002
- This deviceK032459 Profile 1320 Laser SystemSciton, Inc · 2004
- Descendant · cites it directly · 517 of its ownK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
Showing 5 of 518 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 518 · See all- K042000Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004 · cites it directly517descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K820106 | X-Ray Guaze Sponges | Stan-Pak Ent. | 1982 | — |
| −3 | K962791 | New Star Model 130 6-Watt ND: Yag Laser System | New Star Lasers, Inc. | 1997 | — |
| −2 | K014035 | Cooltouch and Cooltouch-II ND:Yag Laser Systems | Cooltouch Corp. | 2002 | — |
| −1 | K022466 | Profile 1320 Laser System | Sciton, Inc | 2002 | — |
| 0 (this device) | K032459 | Profile 1320 Laser System | Sciton, Inc | 2004 | — |
| +1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2002 | 4 | 0 |
| 2003 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 8 | 0 |
| 2008 | 15 | 0 |
| 2009 | 6 | 0 |
| 2010 | 14 | 0 |
| 2011 | 14 | 0 |
| 2012 | 11 | 0 |
| 2013 | 14 | 0 |
| 2014 | 20 | 0 |
| 2015 | 20 | 0 |
| 2016 | 32 | 0 |
| 2017 | 24 | 0 |
| 2018 | 25 | 0 |
| 2019 | 14 | 0 |
| 2020 | 33 | 0 |
| 2021 | 27 | 0 |
| 2022 | 42 | 0 |
| 2023 | 32 | 0 |
| 2024 | 63 | 0 |
| 2025 | 61 | 0 |
| 2026 | 38 | 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? (10)
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 |
|---|---|---|---|
| * | K022466 | Profile 1320 Laser SystemSummary page 1…e: Nd:YAG Laser System Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014… | 2002 |
| * | K022381 | Profile 1320 Laser SystemSummary page 1…Nd:YAG Laser System Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K… | 2002 |
| * | K031184 | Cool Touch 3Summary page 1…gical Instrument, 21 CFR 878.4810. Legally Marketed Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System… | 2003 |
| * | K030453 | Cooltouch ND: Yag Laser SystemSummary page 1…trument, 21 CFR 878.4810. Legally Marketed Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884,… | 2003 |
| * | K022817 | Cooltouch ND:Yag Laser System, Model Cooltouch, Cooltouch-II ND:Yag Laser System, Model…Summary page 1…rketed Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128… | 2002 |
| * | K014035 | Cooltouch and Cooltouch-II ND:Yag Laser SystemsSummary page 1…Profile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128 and K013… | 2002 |
| * | K012982 | Cooltouch VarizoomSummary page 1…ofile 1320 Laser System (K022466, K022381) Predicate Device: CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128 and K013825) Descri… | 2001 |
| * | K022884 | Candela Smoothbeam Laser SystemSummary page 1…CoolTouch Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128 and K013825) Description of Profile 1320 Laser System is an Nd:YAG laser pro… | 2003 |
| * | K014128 | Candela Smoothbeam Laser SystemSummary page 1…h Nd:YAG Laser System (K031184, K030453 K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128 and K013825) Description of Profile 1320 Laser System is an Nd:YAG laser producing Pr… | 2002 |
| * | K013825 | Candela Smoothbeam Laser SystemSummary page 1…K022817, K014035 and K012982) Candela Smoothbeam Laser System (K022884, K014128 and K013825) Description of Profile 1320 Laser System is an Nd:YAG laser producing Profile 1320 Laser System: emission at a… | 2002 |
What descends from it? (518)
See all 5183 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 22 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- 2 of the 20 ancestors have a recall of any class.
- Of its descendants, K042000 (Msq (M2), Ltd., 2004) has gone furthest, with 517 descendants of its own.
- 1 other device also cites its predicate K022466.
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 Sciton, Inc. Profile 1320 Laser is intended for use in general surgery and dermatology for the incision, excision, ablation, vaporization, coagulation, with hemostasis of soft tissue.
It is indicated for the treatment of fine lines and wrinkles. It is also indicated for the treatment of back acne and atrophic acne scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032459 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032459: Profile 1320 Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032459
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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