510(k) · Cleared
ClearedAccela System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Biosystems, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 20, 2008 as substantially equivalent to K053324 (Chromogenex Plc, 2006) and 2 other predicates after a 15-day review. Its family tree reaches back 9 generations to 1992.
- Decided
- Jun 20, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 88 ancestors in all, the oldest K885026 (1989). No later device cites it as a predicate yet.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 1 generation backK053324 Chromolite SystemChromogenex Plc · 2006
- This deviceK081578 Accela SystemGenesis Biosystems, Inc. · 2008
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 4 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK033946 Lovely SystemMsq (M2), Ltd. · 2004
- 1 generation backK053324 Chromolite SystemChromogenex Plc · 2006
- This deviceK081578 Accela SystemGenesis Biosystems, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −2 | K033946 | Lovely System | Msq (M2), Ltd. | 2004 | — |
| −1 | K053324 | Chromolite System | Chromogenex Plc | 2006 | — |
| 0 (this device) | K081578 | Accela System | Genesis Biosystems, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 6 | 0 |
| 1994 | 7 | 0 |
| 1995 | 7 | 0 |
| 1996 | 7 | 0 |
| 1997 | 8 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 7 | 0 |
| 2001 | 7 | 0 |
| 2002 | 9 | 0 |
| 2003 | 6 | 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? (3)
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 |
|---|---|---|---|
| * | K053324 | Chromolite SystemSummary page 2…ical characteristics, performance, intended use, indications for use and operator interface to; • Chromogenex (K053324) * Sciton (K032460) * Lumenis (K020839) System Description:… | 2006 |
| * | K032460 | Profile BBL SystemSummary page 2…indications for use and operator interface to; • Chromogenex (K053324) * Sciton (K032460) * Lumenis (K020839) System Description: The Accela is an Intense Pulsed Light-based medi… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 2…operator interface to; • Chromogenex (K053324) * Sciton (K032460) * Lumenis (K020839) System Description: The Accela is an Intense Pulsed Light-based medical device utilizing xe… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
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 16 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 88 ancestors have a recall of any class.
- 1 other device also cites its predicate K053324.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
Indications for Use for Fitzpatrick skin types (I to VI) The removal of unwanted hair and to effect stable long-term or *permanent hair reduction. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. The treatment of moderate inflammatory acne vulgaris The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) The…
Read the full statement (244 words)
Indications for Use for Fitzpatrick skin types (I to VI)
The removal of unwanted hair and to effect stable long-term or *permanent hair reduction.
*Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
The treatment of moderate inflammatory acne vulgaris
The treatment of benign pigmented epidermal 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, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures.
Reduce pain during and/or 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 - and/or 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)
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/K081578 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081578: Accela System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081578
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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