510(k) · Cleared
ClearedProfile 1064 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 Jun 13, 2003 as substantially equivalent to K002853 (Sciton, Inc, 2000) and 15 other predicates after a 204-day review. Its family tree reaches back 7 generations to 1992. 227 later devices descend from it.
- Decided
- Jun 13, 2003
- Review
- 204 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 16
Its longest line of descent runs back 7 generations to K910422 (1992). 83 ancestors in all, the oldest K820106 (1982). 227 later devices descend from it, 5 citing it directly.
- Root · 7 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 5 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 4 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 3 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 2 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 1 generation backK022226 Altus Medical Family of Coolglide Lasers, Models Coolglide I…Altus Medical, Inc. · 2002
- This deviceK023881 Profile 1064 Laser SystemSciton, Inc · 2003
- 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 · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- Descendant · 3 generations on · 177 of its ownK090164 Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
Showing 5 of 227 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 227 · See all- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
- K090164Ceralas Multiwavelength 980/1470NM Diode LaserBiolitec, Inc. · 2009 · 3 generations on177descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −6 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −5 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −4 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −3 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −2 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −1 | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II… | Altus Medical, Inc. | 2002 | — |
| 0 (this device) | K023881 | Profile 1064 Laser System | Sciton, Inc | 2003 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| +3 | K090164 | Ceralas Multiwavelength 980/1470NM Diode Laser | Biolitec, Inc. | 2009 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 5 | 0 |
| 1994 | 8 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 9 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 10 | 0 |
| 2002 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 10 | 0 |
| 2009 | 3 | 0 |
| 2010 | 8 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 9 | 0 |
| 2015 | 11 | 0 |
| 2016 | 10 | 0 |
| 2017 | 6 | 0 |
| 2018 | 12 | 0 |
| 2019 | 7 | 0 |
| 2020 | 14 | 0 |
| 2021 | 10 | 0 |
| 2022 | 24 | 0 |
| 2023 | 13 | 0 |
| 2024 | 24 | 0 |
| 2025 | 28 | 0 |
| 2026 | 16 | 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? (16)
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 |
|---|---|---|---|
| * | K002853 | Sciton Image Hair Removal LaserSummary page 1…System Common Name: Nd:YAG Laser System Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed Sciton's laser systems (K002853, KO03046 & KO10285). Predicate Device: Altus Medical Aesthetic Nd:YAG Lasers (K991234, K991798, KO0… | 2000 |
| * | K003046 | Image Vascular Laser | 2000 |
| * | K010285 | Contour Profile LaserSummary page 3…The technological characteristics are identical to previous predicate Sciton’s laser systems (K002853, KO03046 & K010285). As a result, the risks and benefits are comparable to the predicate devices.… | 2001 |
| * | K991234 | The Acme Medical Aesthetic ND:Yag LaserSummary page 1…Instrument, 21 CFR 878.4810. Legally Marketed Sciton's laser systems (K002853, KO03046 & KO10285). Predicate Device: Altus Medical Aesthetic Nd:YAG Lasers (K991234, K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured… | 1999 |
| * | K991798 | Acme Medical Aesthetic ND:Yag LaserSummary page 1…ally Marketed Sciton's laser systems (K002853, KO03046 & KO10285). Predicate Device: Altus Medical Aesthetic Nd:YAG Lasers (K991234, K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope… | 2000 |
| * | K003202 | Family of Altus Medical Coolglide Aesthetic Lasers, Models I & II | 2001 |
| * | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide I, II and… | 2002 |
| * | K022226 | Altus Medical Family of Coolglide Lasers, Models Coolglide I, Coolglide II, and Future…Summary page 1…er systems (K002853, KO03046 & KO10285). Predicate Device: Altus Medical Aesthetic Nd:YAG Lasers (K991234, K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147,… | 2002 |
| * | K990718 | Orion Series Surgical Laser System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…, K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactu… | 2000 |
| * | K990903 | Lyra Series Surgical System (SL Seriesq-Switched ND:Yag Configuration)Summary page 1…K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HG… | 1999 |
| * | K003147 | Lyra Series Surgical Laser System (SL Series, ND:Yag Configuration)Summary page 1…K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HGM (K9819… | 2000 |
| * | K003765 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…K991798, KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HGM (K981952). Des… | 2001 |
| * | K010284 | Lyra G Series Surgical Laser System (SL Series Q-Switched ND:Yag Configuration)Summary page 1…KO03202 and KO14040 and K022226); Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HGM (K981952). Description… | 2001 |
| * | K010834 | Lyra Series Surgical Laser System & Accessories | 2001 |
| * | K020021 | Lyra Surgical Laser System and Accessiories (ND:Yag Configuration)Summary page 1…Lyra/Orion Laser Systems manufactured by Laserscope (K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HGM (K981952). Description of Profile Laser System is an Nd:YAG… | 2002 |
| * | K981952 | Combination ND:Yag and Frequency Doubled Solid State Green LaserSummary page 1…(K990718, K990903,K003147, K003765, K010284, KO10834 and K020021); and VeinLase, manufactured by HGM (K981952). Description of Profile Laser System is an Nd:YAG laser producing Profile Laser System: emission at a wavelength of… | 1998 |
What descends from it? (227)
See all 2275 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 11 years and passes through 5 companies; a new generation was cleared every 1.2 years on median.
- 3 of the 83 ancestors have a recall of any class.
- Of its descendants, K060033 (Sciton, Inc, 2006) has gone furthest, with 221 descendants of its own.
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 Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications. Dermatology: Coagulation and hemostasis of benign vascular lesions such as, but not limited to port…
Read the full statement (338 words)
The Profile 1064 Laser Systems and Accessories are intended for use in the medical specialties of general and plastic surgery, dermatology, endoscopic/laproscopic general surgery, gastroenterology, gynecology, otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, pulmonary/thoracic surgery and urology for surgical and aesthetic applications.
Dermatology:
Coagulation and hemostasis of benign vascular lesions such as, but not limited to port wine stains, hemangiomas, warts, telangiectasia, rosacea, Venus lake, leg veins and spider veins. The lasers are also intended for the treatment of benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratoses, tattoos (significant reduction in the intensity of black and/or blue/black tattoos) and plaques. Additionally, the lasers are 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.
Removal of unwanted hair, for the stable long term, or permanent hair reduction through selective targeting of melanin in hair follicles, and for the treatment for pseudofolliculitis barbae (PFB). The Profile 1064 Laser Systems and Accessories are indicated for use on all skin types (Fitzpatrick I-VI), including tanned skin.
The Profile 1064 Laser Systems and Accessories are indicated for the treatment of facial wrinkles.
The intended use of the contact cooling system in the Profile handpiece is to provide cooling of the skin prior to, during and after laser treatment, for the epidermal protection and reduction of pain during laser treatment, to allow for the use of higher fluences for laser treatments such as hair removal and vascular lesions, and to reduce the potential side effects of laser treatments.
Surgical Applications:
Incision/excision and cutting, ablation, coagulation/hemostasis of soft tissue in the performance of surgical applications in endoscopy/laparoscopy, gastroenterology, general surgery, head and neck/otorhinolaryngology (ENT), neurosurgery, oculoplastics, orthopedics, plastic surgery, pulmonary/thoracic surgery, gynecology (e.g. menorrhagia) and urology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K023881 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023881: Profile 1064 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/K023881
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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