510(k) · Cleared
ClearedProfile BBL 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 Nov 13, 2003 as substantially equivalent to K030527 (Lumenis, 2003) and 3 other predicates after a 94-day review. Its family tree reaches back 7 generations to 1992. 569 later devices descend from it.
- Decided
- Nov 13, 2003
- Review
- 94 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 7 generations to K910422 (1992). 63 ancestors in all, the oldest K892514 (1990). 569 later devices descend from it, 10 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 backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 2 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 1 generation backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- This deviceK032460 Profile BBL SystemSciton, Inc · 2003
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 238 of its ownK050841 Fraxel SR Laser SystemReliant Technologies, Inc. · 2005
- Descendant · 2 generations on · 230 of its ownK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- Descendant · 2 generations on · 226 of its ownK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
Showing 5 of 569 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 569 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K050841Fraxel SR Laser SystemReliant Technologies, Inc. · 2005 · cites it directly238descendants
- K060310Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006 · 2 generations on230descendants
- K062303Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007 · 2 generations on226descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
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 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −1 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| 0 (this device) | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K050841 | Fraxel SR Laser System | Reliant Technologies, Inc. | 2005 | — |
| +2 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| +2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 6 | 0 |
| 2001 | 3 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 8 | 0 |
| 2007 | 11 | 0 |
| 2008 | 23 | 0 |
| 2009 | 16 | 0 |
| 2010 | 15 | 0 |
| 2011 | 18 | 0 |
| 2012 | 12 | 0 |
| 2013 | 22 | 0 |
| 2014 | 24 | 0 |
| 2015 | 25 | 0 |
| 2016 | 35 | 0 |
| 2017 | 29 | 0 |
| 2018 | 26 | 0 |
| 2019 | 20 | 0 |
| 2020 | 32 | 0 |
| 2021 | 24 | 0 |
| 2022 | 44 | 0 |
| 2023 | 38 | 0 |
| 2024 | 56 | 0 |
| 2025 | 58 | 0 |
| 2026 | 30 | 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 |
|---|---|---|---|
| * | K030527 | Lumenis Family of Ipl and Combination Ipl/ND:Yag SystemsSummary page 1…red Surgical Device (and Accessories) Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed Lumenis Family of Intense Pulsed-Light (K030527, Predicate Device: K020839) Palomar EsteLux (K020453) Altus Medical CoolGlide… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…ries) Classification Name: Laser Surgical Instrument, 21 CFR 878.4810. Legally Marketed Lumenis Family of Intense Pulsed-Light (K030527, Predicate Device: K020839) Palomar EsteLux (K020453) Altus Medical CoolGlide with Optional Pulsed Light Hand… | 2002 |
| * | K020453 | Palomar Estelux Pulsed Light System and Palomar CoolrollerSummary page 1…rument, 21 CFR 878.4810. Legally Marketed Lumenis Family of Intense Pulsed-Light (K030527, Predicate Device: K020839) Palomar EsteLux (K020453) Altus Medical CoolGlide with Optional Pulsed Light Hand Piece (K023954) Descripti… | 2002 |
| * | K023954 | Altus Medical Coolglide Laser Systems and AccessoriesSummary page 1…K020839) Palomar EsteLux (K020453) Altus Medical CoolGlide with Optional Pulsed Light Hand Piece (K023954) Description of Profile BBL System emits intense wide spectrum Profile BBL System: emission with wavelength of 500-14… | 2003 |
What descends from it? (569)
See all 56910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 | 266 |
| K050841 | Fraxel SR Laser System | 2005 | 238 |
| K060033 | Profile Multi-Platform System | 2006 | 221 |
| K082033 | Nannolight Intense Pulsed Light System | 2008 | 159 |
| K050047 | Cutera Optional Pulsed Light Hand Piece Family | 2005 | 109 |
| K082484 | Accelawave System | 2008 | 29 |
| K123860 | Inmode SR Ipl Device | 2013 | 3 |
| K111350 | Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System | 2011 | 0 |
| K081578 | Accela System | 2008 | 0 |
| K063060 | Blueshine Light Shine Systems, SP, Twin and Compact SP | 2006 | 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 11 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 1 of the 63 ancestors has a recall of any class.
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 descendants of its own.
- 5 other devices also cite its predicate K030527.
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 BBL (and the light andlor laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of tattoos; The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma…
Read the full statement (274 words)
The Profile BBL (and the light andlor laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology.
It is intended for use for:
The treatment of tattoos;
The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles);
The treatment of cutaneous lesions including warts, scars and striae;
The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations;
Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and
The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction.
The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to:
Reduce pain during andlor associated with light or laser treatment (via partial anesthesia from cooling);
Reduce discomfort during and/or associated with light or laser treatment;
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- andlor hypopigmentation;
Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and
Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032460: Profile BBL System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032460
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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