510(k) · Cleared
ClearedFusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eclipsemed Global, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Jan 5, 2010 as substantially equivalent to K060448 (Lumenis, Ltd., 2006) and 1 other predicate after a 60-day review. Its family tree reaches back 15 generations to 1995.
- Decided
- Jan 5, 2010
- Review
- 60 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 15 generations to K943450 (1995). 239 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK093465 Fusion SystemEclipsemed Global, Inc. · 2010
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK093465 Fusion SystemEclipsemed Global, Inc. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K093465 | Fusion System | Eclipsemed Global, Inc. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 11 | 0 |
| 1995 | 11 | 0 |
| 1996 | 16 | 0 |
| 1997 | 21 | 0 |
| 1998 | 15 | 0 |
| 1999 | 9 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 30 | 0 |
| 2003 | 21 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 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 18.1 · 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? (2)
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 |
|---|---|---|---|
| * | K060448 | Lumenis One Family of Systems; Lumenis One.Summary page 1…, laser 79-GEX, 21 CIFR 878-48, Legally Marketed Predicate Lumenis One Family of Systems Device: K060448 Alma Harmony XL (for treatment of Acne) K072564 Descrip… | 2006 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 1…y of Systems Device: K060448 Alma Harmony XL (for treatment of Acne) K072564 Description of the Fusion The Fusion System consists of: System: * The main console u… | 2008 |
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 15 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 9 of the 239 ancestors have a recall of any class.
- 4 other devices also cite its predicate K060448.
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. 2010, 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 500 - l200nm intense pulsed light wavelengths are indicated for: * The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles) * The treatment of cutaneous lesions, including warts, scars and striae The 560 - l200nm intense pulsed light wavelengths are indicated for: * The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg…
Read the full statement (142 words)
The 500 - l200nm intense pulsed light wavelengths are indicated for:
* The treatment of benign pigmented epidermal lesions, including dyschromia, hyperpigmentation, melasma, ephelides (freckles)
* The treatment of cutaneous lesions, including warts, scars and striae
The 560 - l200nm intense pulsed light wavelengths are indicated for:
* The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikilodlerma of Civatte, leg veins and venous malformations
The 600 - 1200nm intense pulsed light wavelengths are indicated for:
* The removal of unwanted hair from all skin types and to effect stable, long-term or permanent hair reduction in skin types I-V through selective targeting of melanin in hair follicles.
The 400 - i200nm intense pulsed light wavelengths are indicated for:
* The treatment of moderate inflammatory acne vulgaris.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093465 · printed Nov 6, 2026
Cite this page
510(k) Report. “K093465: Fusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K093465
Report an extraction error
Are you the manufacturer?
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