510(k) · Cleared
ClearedMedicam Evolux, Evostar, Evolight and Evolase Pulsed Light System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medicam, Inc. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Sep 29, 2011 as substantially equivalent to K032460 (Sciton, Inc, 2003) and 1 other predicate after a 139-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- Sep 29, 2011
- Review
- 139 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K910422 (1992). 64 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 8 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 7 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 6 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 5 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 4 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 3 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 2 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 1 generation backK032460 Profile BBL SystemSciton, Inc · 2003
- This deviceK111350 Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light SystemMedicam, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −7 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −6 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −5 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −4 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −2 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −1 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| 0 (this device) | K111350 | Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System | Medicam, Inc. | 2011 | — |
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 |
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 |
|---|---|---|---|
| * | K032460 | Profile BBL SystemSummary page 1…r use in General and Plastic Surgery and in Dermatology (21 CER 878.4810) Legally Marketed >Profile BBL System (K032460) Predicate Devices Quantum, Models SR, HR, DL (K020839) System Description Medicam Evolux… | 2003 |
| * | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLSummary page 1…Dermatology (21 CER 878.4810) Legally Marketed >Profile BBL System (K032460) Predicate Devices Quantum, Models SR, HR, DL (K020839) System Description Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light Systems emit… | 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 19 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 64 ancestors has a recall of any class.
- 9 other devices also cite its predicate K032460.
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. 2011, 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 Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue. It is intended for use for: >Removal of unwanted hair from all skin types (640nm to 1200nm); >Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides…
Read the full statement (185 words)
The Medicam Evolux, Evostar and Evolight pulsed light systems (and included accessories) are indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue.
It is intended for use for:
>Removal of unwanted hair from all skin types (640nm to 1200nm);
>Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (510nm to 1200nm);
> Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins(485 nm to 1200nm); and
> Treatment of benign cutaneous lesions including warts, scars and striae (420nm to 1200nm).
The Medicam Evolase pulsed light system (and included accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue.
It is intended for use for:
> Treatment of benign pigmented lesions including dyschromia, hyper pigmentation, melasma, ephelides (freckles) (1064nm to 1200nm); and
> Removal of benign cutaneous vascular lesions including port wine stains, hemangiomas, rosacea, erythema, leg veins (532nm to 1200nm).
The devices are intended for prescription use.
The device is intended for prescription use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111350 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111350: Medicam Evolux, Evostar, Evolight and Evolase Pulsed Light System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111350
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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