← Product Code [NRB](/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB) · DEN040004

# CELLERATION MIST THERAPY SYSTEM (DEN040004)

_Celleration · NRB · Jun 25, 2004 · General, Plastic Surgery · DENG_

**Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/DEN040004

## Device Facts

- **Applicant:** Celleration
- **Product Code:** [NRB](/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB.md)
- **Decision Date:** Jun 25, 2004
- **Decision:** DENG
- **Submission Type:** Post-NSE
- **Regulation:** 21 CFR 878.4410
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery

## Regulatory Identification

A low energy ultrasound wound cleaner is a device that uses ultrasound energy to vaporize a solution and generate a mist that is used for the cleaning and maintenance debridement of wounds. Low levels of ultrasound energy may be carried to the wound by the saline mist.

## Special Controls

*Classification.* Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Low Energy Ultrasound Wound Cleaner.” See § 878.1(e) for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/DEN040004](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/NRB/DEN040004)

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