# K003541: Denlaser, Model 800

- Pathway: 510(k) (Traditional)
- Applicant: CAO Group, Inc.
- Decided: Jan 25, 2001 after 70 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
87 later devices descend from it; 1 cites it directly.
0 of 88 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050 (2005), 86 descendants of its own
- K062258: Genesis Diode Laser (2007), 71 descendants of its own
- K081214: Styla Microlaser and Stylaortho (2008), 50 descendants of its own
- K062619: Denlaser 800 Plus (2006), 40 descendants of its own
- K093852: Ezlase 3 Laser System (2010), 35 descendants of its own

## Recalls of this device
- Jul 23, 2007 · Not classified · Z-0271-2008: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissi
- Jul 23, 2007 · Not classified · Z-0273-2008: Incorrect Data Results - ECAT System's software versions 7.2.2 and 7.4 may calculate the decay correction for emission data incorrectly while performing whole-body studies with all transmissions follo
- Jul 23, 2007 · Not classified · Z-0251-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0252-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0270-2008: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissi
- Jul 23, 2007 · Not classified · Z-0246-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0247-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0249-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0248-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0250-2008: Visual asymmetric appearance; An asymmetry can be introduced into the attenuation-corrected PET images when using iterative reconstruction in combination with a specific number of subsets and reconstr
- Jul 23, 2007 · Not classified · Z-0269-2008: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissi
- Jul 23, 2007 · Not classified · Z-0272-2008: Incorrect Decay Correction Results - ECAT System's software versions 7.2.2 and 7.4 calculate the decay correction for emission data incorrectly, while performing whole-body studies with all transmissi

Source page: https://510kreport.com/device/K003541
Methodology: https://510kreport.com/methodology