510(k) · Cleared
ClearedMediflash and Esteflash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dermeo · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on May 21, 2010 as substantially equivalent to K060234 (Mccue Plc, 2006) after a 226-day review. Its family tree reaches back 8 generations to 1992.
- Decided
- May 21, 2010
- Review
- 226 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K910422 (1992). 67 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 backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 3 generations backK020453 Palomar Estelux Pulsed Light System and Palomar CoolrollerPalomar Medical Technologies, Inc. · 2002
- 2 generations backK040659 Mccue PLC Energist Ultra Variable Pulsed Light SystemMccue Plc · 2004
- 1 generation backK060234 Mccue Energist Ultra VPL Intense Pulse Light SystemMccue Plc · 2006
- This deviceK093168 Mediflash and EsteflashDermeo · 2010
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 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −3 | K020453 | Palomar Estelux Pulsed Light System and Palomar Coolroller | Palomar Medical Technologies, Inc. | 2002 | — |
| −2 | K040659 | Mccue PLC Energist Ultra Variable Pulsed Light System | Mccue Plc | 2004 | — |
| −1 | K060234 | Mccue Energist Ultra VPL Intense Pulse Light System | Mccue Plc | 2006 | — |
| 0 (this device) | K093168 | Mediflash and Esteflash | Dermeo | 2010 | — |
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 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 1 | 0 |
| 2005 | 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? (1)
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 |
|---|---|---|---|
| * | K060234 | Mccue Energist Ultra VPL Intense Pulse Light SystemSummary page 1…ent Device Company Product 510(k) # McCue Plc McCue Energist Ultra Variable Pulsed Light K060234 DEVICE DESCRIPTION 807.92(a)(4) The MEDIFLASH3 and ESTHEFLASH3 Intense Pulsed Light D… | 2006 |
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 18 years and passes through 6 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 67 ancestors has a recall of any class.
- 2 other devices also cite its predicate K060234.
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 MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows: Intense Pulsed Light Energy/Wavelengths (420nm-1200nm) * The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of…
Read the full statement (312 words)
The MEDIFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:
Intense Pulsed Light Energy/Wavelengths (420nm-1200nm)
* The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, melasma, angiomas and spider angiomas, poikiloderma of Civatte, leg veins, facial veins and venous malformations for Fitzpatrick Skin types I-III (Wavelengths - 515 - 1200 nm, or 500-600 and 870 - 1200nm)
* The treatment of benign pigmented epidermal and cutaneous lesions including scars and striae for Fitzpatrick Skin types I-III (Wavelengths -550- 1200 nm)
* Treatment of inflammatory acne (acne vulgaris) for Fitzpatrick Skin types I-III (Wavelengths 420 - 1200 nm)
* Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). MEDIFLASH3 cannot be used for skin type VI.
*Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.
The ESTHEFLASH3 Intense Pulsed Light device is indicated for use in medical and aesthetic applications requiring selective photothermolysis for dermatological and medical aesthetic treatments as follows:
* Removal of unwanted hair from all skin types and to effect stable long term or permanent* hair reduction through selective targeting of melanin in hair follicles. (Light skin for Fitzpatrick Skin types I-IV Wavelengths - 620 - 1200 nm, Dark Skin for Fitzpatrick Skin types IV and V 690 - 1200 nm). ESTHEFLASH-3 cannot be used for skin type VI.
*Permanent hair reduction is defined as a long term stable reduction in the number of hairs regrowing after a treatment regime.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K093168 · printed Nov 4, 2026
Cite this page
510(k) Report. “K093168: Mediflash and Esteflash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K093168
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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