# K964520: Parascan Scanning Device

- Pathway: 510(k) (Traditional)
- Applicant: Laserscope
- Decided: Feb 10, 1997 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: 1 generation back to K955734 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955734: Lasersonics Parascan Dosimeter Device, Heraeus Surgical, Inc. (1996) Summary page 3.

## Most influential descendants
- K974633: Scantech Laser Scanner (1998), 0 descendants of its own

## Indications for use
The ParaScan Scanning Device and CBH-1 Collimated Beam Handpiece are intended for soft tissue indications (CO, soft tissue clearances previously obtained by Heraeus Surgical). In addition, indications include treatment of wrinkleg/rhytides; solar/actinic elastosis; keratoses; lentigos; laser skin resurfacing; laser resurfacing; laserbrasion; scar revision; warts; periorbital syringomas; epidermal nevi; rhinophyma; xanthelasma; actinic cheilitis and debulking benign tumors.

Source page: https://510kreport.com/device/K964520
Methodology: https://510kreport.com/methodology