# K974633: Scantech Laser Scanner

- Pathway: 510(k) (Traditional)
- Applicant: Phantom Technologies, Inc.
- Decided: Jan 16, 1998 after 35 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: 3 generations back to K955734 (1996). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960032: Coherent Versapulse Aesthetic Surgical Lasers, Coherent Medical Group (1996) Summary page 2.
- K951812: Modified Coherent Ultrapulse CO2 Surgical Lasers, Lumenis, Inc. (1995) Summary page 2.
- K946304: Coherent Family of CO2 Surgical Laser Scanner Handpieces, Lumenis, Inc. (1995). Our OCR of the scanned summary read K943604, FDA’s number for Integral V Biointegrated Dental Implant System (Calcitek, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Coherent”.
- K962242: Surescan, Clinicon Corp. (1996) Summary page 2.
- K964520: Parascan Scanning Device, Laserscope (1997) Summary page 2.
- K955734: Lasersonics Parascan Dosimeter Device, Heraeus Surgical, Inc. (1996) Summary page 2.
- K941841: Smartscan, Laserscope (1994) Summary page 2.
- K964684: Softouch, Sahar Technologies, Inc. (1997) Summary page 2.
- K961935: Sharplan Lasers, Inc. Silktouch CO2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 2.
- K960820: Sharplan Lasers, Inc. Silktouch XJ Scanner, Sharplan Lasers, Inc. (1996) Summary page 2.
- K960521: Sharplan Lasers, Inc. Silktouch Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 2.
- K955621: Sharplan Lasers, Inc Silktouch 2 Flash Scanner, Sharplan Lasers, Inc. (1996) Summary page 2.

## Indications for use
The ScanTech laser scanning handpiece is designed for use in surgical applications requirdng the exdision, incision, ablation, vaporization, and coaguiation and photo thermolysis of soft lissue in medical specialties including: general surgery, plastic surgery, aesthetic surgery, demnatology, ophthalmology (imited to periobital demmis).

Source page: https://510kreport.com/device/K974633
Methodology: https://510kreport.com/methodology