# K082484: Accelawave System

- Pathway: 510(k) (Traditional)
- Applicant: Genesis Biosystems, Inc.
- Decided: Sep 12, 2008 after 15 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: 9 generations back to K910422 (1992). 88 ancestors in all.
29 later devices descend from it; 2 cite it directly.
0 of 118 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.

## Most influential descendants
- K093627: Ipulselight Ipl System, Models HS 300C and HS 650 (2011), 24 descendants of its own
- K122995: Intense Pulsed Light (Ipl) Systems (2013), 16 descendants of its own
- K200746: IPL Treatment Systems (2020), 5 descendants of its own
- K161286: IPL Therapy Machine (2016), 5 descendants of its own
- K192521: Intense Pulsed Light Treatment System (2019), 3 descendants of its own

## Indications for use
The removal of unwanted hair and to effect stable long-term or *pennanent 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 treatment in general aesthetic dermatologic and plastic surgery procedures. Reduce pain during light treatment (via partial anaesthesia from cooling) Reduce discomfort during and/or associated with light treatment Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarming, hyper — and/or hypo pigmentation Allow the use of higher light or laser fluences for light treatments (such as for hair removal and the treatment of vascular or pigmented lesions) Reduce potential side effects of light treatments (such as for hair removal and the treatment of vascular or pigmented lesions)

Source page: https://510kreport.com/device/K082484
Methodology: https://510kreport.com/methodology