# K051508: Med Flash II Intense Pulsed Light System.

- Pathway: 510(k) (Traditional)
- Applicant: General Project S.R.L.
- Decided: Oct 5, 2005 after 120 days
- Product code: GEX (Powered Laser Surgical Instrument)
- 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: 9 generations back to K910422 (1992). 73 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 82 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041086: Palomar Starlux Pulsed Light System, Palomar Medical Products, Inc. (2005) Summary page 1.
- K033549: Starlux Pulsed Light System, Palomar Medical Products, Inc. (2004) Summary page 1.
- K040081: Palomar Luxv Handpiece, Palomar Medical Technologies, Inc. (2004) Summary page 1.
- K020941: Palomar Luxg Handpiece, Palomar (2002) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K043319: Clareon and Solarus Pulsed Light Devices and Accessories, Novalis Medical, LLC (2004) Summary page 1.
- K050047: Cutera Optional Pulsed Light Hand Piece Family, Cutera, Inc. (2005) Summary page 1.
- K041095: Photosilk Pulsed Light System, Cynosure, Inc. (2004) Summary page 1.
- K022583: FLASH 1, Emed, Inc. (2002) Summary page 1.

## Most influential descendants
- K072331: Radiancy Mistral Device (2008), 6 descendants of its own
- K091664: GSD Intense Pulsed Light System, Models: GP666C4, GP666C (2009), 4 descendants of its own
- K102857: Ahwon's Ipl System (2011), 2 descendants of its own
- K181868: SHINY RPL System (2018), 1 descendant of its own
- K220794: 10PL (2022), 0 descendants of its own

## Indications for use
The MED flash II Intense Pulsed Light System is indicated for use in: * Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction * Treatment of inflammatory acne (acne vulgaris) * Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafd-au-lait * Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins * The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.

Source page: https://510kreport.com/device/K051508
Methodology: https://510kreport.com/methodology