# K964831: Surescan

- Pathway: 510(k) (Traditional)
- Applicant: Clinicon Corp.
- Decided: Aug 8, 1997 after 249 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: 2 generations back to K955734 (1996). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K901008: Hexascan Handpiece, Lihtan Technologies, Inc. (1990) Summary page 1.
- K962242: Surescan, Clinicon Corp. (1996) Summary page 1.
- (no number) CPG - Coherent Medical Inc: named in the summary without a submission number

## Indications for use
CAUTION SureScan use is restricted for adaptation to laser systems that have received FDA clearance for cutaneous surgical applications and soft tissue ablation at the following specific wavelengths: 488nm, 511nm, 514nm, 520nm, 530nm, 532nm, 568nm, 577nm, 578nm, 585nm, 694nm, 752nm, 1064nm, 2940nm. Users should refer to the laser manufacturer’s operating manual for applications that have been cleared for the specific wavelength. SureScan Wavelengths & Indications for Use (Consult Manufacturer’s Manual for Cleared Applications) 488nm Blue/Green CWArgon Epidermal vascular lesions 511nm Green Pulsed Copper Vapor Epidermal vascular lesions 514nm Green CWArgon Epidermal vascular lesions 520nm Green CWKrypton Epidermal vascular lesions 530nm Green CWKrypton Epidermal vascular & Pigm. Lesions 532nm Green CW/Pulsed KTP YAG Epidermal vascular & Pigm. Lesions 568nm Yellow CWKrypton Epidermal vascular & Pigm. Lesions 577nm Yellow CWDye Epidermal vascular & Pigm. Lesions 578nm Yellow Pulsed Copper Vapor Epidermal vascular & Pigm. Lesions 585nm Yellow CWDye Epidermal vascular & Pigm. Lesions 694nm Red Pulsed Ruby Epid. Pigm. Lesions & Tattoos 752nm Red Pulsed Alexandrite Epid. Pigm. Lesions & Tattoos 1064nm IR Pulsed Nd:YAG Epidermal Pigmented Lesions 2940nm IR CWErYAG Soft Tissue Ablation

Source page: https://510kreport.com/device/K964831
Methodology: https://510kreport.com/methodology