# K081578: Accela System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Biosystems, Inc.
- Decided: Jun 20, 2008 after 15 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). 88 ancestors in all.
No later device cites it as a predicate yet.
0 of 89 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K053324: Chromolite System, Chromogenex Plc (2006) Summary page 2.
- K032460: Profile BBL System, Sciton, Inc (2003) Summary page 2.
- K020839: Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL, Lumenis, Inc. (2002) Summary page 2.

## Indications for use
Indications for Use for Fitzpatrick skin types (I to VI) The removal of unwanted hair and to effect stable long-term or *permanent hair reduction. *Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. The treatment of moderate inflammatory acne vulgaris The treatment of benign pigmented epidermal 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, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures. Reduce pain during and/or 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 - and/or 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) 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/K081578
Methodology: https://510kreport.com/methodology