# K093168: Mediflash and Esteflash

- Pathway: 510(k) (Traditional)
- Applicant: Dermeo
- Decided: May 21, 2010 after 226 days
- Product code: ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K910422 (1992). 67 ancestors in all.
No later device cites it as a predicate yet.
0 of 68 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060234: Mccue Energist Ultra VPL Intense Pulse Light System, Mccue Plc (2006) Summary page 1.

## Indications for use
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.

Source page: https://510kreport.com/device/K093168
Methodology: https://510kreport.com/methodology