510(k) · Cleared
ClearedAccelawave System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Genesis Biosystems, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Sep 12, 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. 29 later devices descend from it.
- Decided
- Sep 12, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 88 ancestors in all, the oldest K885026 (1989). 29 later devices descend from it, 2 citing it directly.
- 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 deviceK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
- Descendant · cites it directly · 24 of its ownK093627 Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011
- Descendant · 2 generations on · 16 of its ownK122995 Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013
- Descendant · 2 generations on · 5 of its ownK200746 IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 5 of its ownK161286 IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016
- Descendant · 3 generations on · 3 of its ownK192521 Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019
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 deviceK082484 Accelawave SystemGenesis Biosystems, Inc. · 2008
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K093627Ipulselight Ipl System, Models HS 300C and HS 650Shanghai Apolo Medical Technologies Co., Ltd. · 2011 · cites it directly24descendants
- K122995Intense Pulsed Light (Ipl) SystemsBeijing Kes Biology Technology Co., Ltd. · 2013 · 2 generations on16descendants
- K200746IPL Treatment SystemsShanghai Apolo Medical Technology Co., Ltd. · 2020 · 2 generations on5descendants
- K161286IPL Therapy MachineBeijing Adss Development Co., Ltd. · 2016 · 3 generations on5descendants
- K192521Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd. · 2019 · 3 generations on3descendants
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) | K082484 | Accelawave System | Genesis Biosystems, Inc. | 2008 | — |
| +1 | K093627 | Ipulselight Ipl System, Models HS 300C and HS 650 | Shanghai Apolo Medical Technologies Co., Ltd. | 2011 | — |
| +2 | K122995 | Intense Pulsed Light (Ipl) Systems | Beijing Kes Biology Technology Co., Ltd. | 2013 | — |
| +2 | K200746 | IPL Treatment Systems | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +3 | K161286 | IPL Therapy Machine | Beijing Adss Development Co., Ltd. | 2016 | — |
| +3 | K192521 | Intense Pulsed Light Treatment System | Shangdong Huamei Technology Co., Ltd. | 2019 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 1 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.2 · 27 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…System is substantially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface to; » Chromogenex (K053324) e Sciton (K032460) e Lumenis (K020839) System Description: The Accelawave is an Intense Pulsed Light-based medical device utili… | 2006 |
| * | K032460 | Profile BBL SystemSummary page 2…ially equivalent in terms of technological characteristics, performance, intended use, indications for use and operator interface to; » Chromogenex (K053324) e Sciton (K032460) e Lumenis (K020839) System Description: The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash la… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 2…terms of technological characteristics, performance, intended use, indications for use and operator interface to; » Chromogenex (K053324) e Sciton (K032460) e Lumenis (K020839) System Description: The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to ill… | 2002 |
What descends from it? (29)
See all 292 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 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.
- Of its descendants, K093627 (Shanghai Apolo Medical Technologies Co., Ltd., 2011) has gone furthest, with 24 descendants of its own.
- 1 other device also cites its predicate K053324.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The removal of unwanted hair and to effect stable long-term or *pennanent 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…
Read the full statement (221 words)
The removal of unwanted hair and to effect stable long-term or *pennanent 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 treatment in general aesthetic dermatologic and plastic surgery procedures.
Reduce pain during light treatment (via partial anaesthesia from cooling)
Reduce discomfort during and/or associated with light treatment
Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarming, hyper — and/or hypo pigmentation
Allow the use of higher light or laser fluences for light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
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/K082484 · printed Nov 5, 2026
Cite this page
510(k) Report. “K082484: Accelawave System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K082484
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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