# K030181: International Biophysics Corporation (Ibc) Laser Peel System

- Pathway: 510(k) (Traditional)
- Applicant: International Biophysics Corp.
- Decided: Apr 17, 2003 after 90 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: 4 generations back to K954013 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954013: Trilase 2940 Erbium Laser, Schwartz Electro-Optics, Inc. (1996)
- K970461: Cell Robotics ER: Yag Surgical Laser, Cell Robotics, Inc. (1997) Summary page 1.
- K014057: Dermastar ER:Yag Laser System, Asclepion-Meditec AG (2002)

## Indications for use
The International Biophysics Corporation Laser Peel system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery), oral surgery, and ophthalmology.

Source page: https://510kreport.com/device/K030181
Methodology: https://510kreport.com/methodology