# K032460: Profile BBL System

- Pathway: 510(k) (Traditional)
- Applicant: Sciton, Inc
- Decided: Nov 13, 2003 after 94 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: 7 generations back to K910422 (1992). 63 ancestors in all.
569 later devices descend from it; 10 cite it directly.
0 of 633 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030527: Lumenis Family of Ipl and Combination Ipl/ND:Yag Systems, Lumenis (2003) Summary page 1.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 1.
- K020453: Palomar Estelux Pulsed Light System and Palomar Coolroller, Palomar Medical Technologies, Inc. (2002) Summary page 1.
- K023954: Altus Medical Coolglide Laser Systems and Accessories, Altus Medical, Inc. (2003) Summary page 1.

## Most influential descendants
- K072564: Alma Lasers Harmony XL Multi-Application Platform (2008), 266 descendants of its own
- K050841: Fraxel SR Laser System (2005), 238 descendants of its own
- K060310: Fraxel II SR Laser System and Accessories (2006), 230 descendants of its own
- K062303: Fraxel II SR Laser System (2007), 226 descendants of its own
- K060033: Profile Multi-Platform System (2006), 221 descendants of its own

## Indications for use
The Profile BBL (and the light andlor laser delivery accessories) is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. It is intended for use for: The treatment of tattoos; The treatment of benign pigmented lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles); The treatment of cutaneous lesions including warts, scars and striae; The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, engiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations; Treatment of psoriasis, vitiligo, atopic dermatitis (eczema), seborrheic dermatitis; and The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent, hair reduction. The integral thermo-electric cooler is indicated for use in cooling the epidermis at the treatment site prior to, during and after light or laser treatment in general surgery, plastic surgery and dermatology to: Reduce pain during andlor associated with light or laser treatment (via partial anesthesia from cooling); Reduce discomfort during and/or associated with light or laser treatment; Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper- andlor hypopigmentation; Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions); and Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions).

Source page: https://510kreport.com/device/K032460
Methodology: https://510kreport.com/methodology