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510(k) K082484

ACCELAWAVE SYSTEM by Genesis Biosystems, Inc. — Product Code ONF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 2008
Date Received
August 28, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Device Class
Class II
Regulation Number
878.4810
Review Panel
SU
Submission Type

A light based non-laser device that provides thermal effect including broad spectrum source devices such as intense pulse light (ipl). Typically, indicated to be used in medical specialties of general and plastic surgery and of dermatology/aesthetic. Indication for use can be general and/or specific.The classification regulation 21 cfr 878.4810 describes a device that is carbon dioxide or argon laser intended to cut, destroy, or remove tissue by the light.

Other clearances by Genesis Biosystems, Inc.

  • K172714 — LipiVage (December 8, 2017)
  • K131142 — GENESIS LED WANDS (November 27, 2013)
  • K081578 — ACCELA SYSTEM (June 20, 2008)

Other clearances for product code ONF

  • K251545 — Intense Pulsed Light Therapy Device (MMABM-1) (September 4, 2025)
  • K231952 — MEDILIGHT (September 3, 2025)
  • K243123 — IPL Treatment Device (MDSQMC-01) (July 3, 2025)
  • K250281 — DEKA LOTUS (February 26, 2025)
  • K242440 — Intense Pulsed Light Treatment System (LK-PT) (November 14, 2024)
  • K240314 — MULA (K2-A1) (August 21, 2024)
  • K240482 — Intense Pulsed Light System (ST-690) (May 17, 2024)
  • K233473 — DEKA LOTUS (May 16, 2024)
  • K233307 — Intensity Pulsed Light Therapy System (March 15, 2024)
  • K232708 — Intense pulsed light therapy device (December 1, 2023)