# Denlaser, Model 800 > Active: United States. Medical device record on deviCERTS, compiled from public registries. - Canonical page: - Manufacturer: [Cao Group, Inc.](https://devicerts.com/manufacturers/cao-group-inc) (United States) - Name in the registry: DENLASER, MODEL 800 - Device class: Class II (US FDA) - FDA product code: GEX ## Registrations and authorizations - **510(k)** · FDA 510(k) · United States · K003541 · decision 2001-01-25 · decision SESE · status: Active ## Recalls - Z-0271-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 transmissions followed by all emissions. - Z-0269-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 transmissions followed by all emissions. - Z-0270-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 transmissions followed by all emissions. - Z-0249-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0250-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0247-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0246-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0273-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 followed by all emissions. - Z-0251-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0252-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) - Z-0272-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 transmissions followed by all emissions. - Z-0248-2008 · · terminated · initiated 2007-07-23 · matched through shared submission K003541, may concern other models: 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 reconstruction matrix sizes. (This problem only occurs when using protocols other than the default Biograph protocols) ## Identifiers - 510(k) Number: K003541 [FDA 510(k)] - FDA product code: GEX [FDA 510(k)] ## Classification - Device class: Class II [FDA 510(k)] - Regulation: 21 CFR Part 878.4810 [FDA 510(k)] - Advisory committee: General, Plastic Surgery [FDA 510(k)] - FDA decision: SESE [FDA 510(k)] ## Source and citation - Cite as: Denlaser, Model 800, Cao Group, Inc. deviCERTS medical device catalogue. https://devicerts.com/devices/denlaser-model-800-gex (data as of 2026-11-15). - Data sources: [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA recalls](https://open.fda.gov/apis/device/recall/) - Registry records last synced: 2026-10-22 - Statuses computed as of: 2026-11-15 - JSON: - Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms. - Attribution: DevicErts, https://devicerts.com/devices/denlaser-model-800-gex - Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.