Aurora DS Modification
510(k) K033586
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK033586 | Date10 Dec 2003 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Modification to Aurora Ds
- 510(k) Number
- FDA Product Code
- GEX
- FDA applicant
- Syneron Medical, Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 878.4810
- Advisory Committee
- General, Plastic Surgery
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Aurora DS Modification is a laser hair removal device classified under the nomenclature for non-invasive hair removal systems. It employs selective thermolysis using optical and radiofrequency (RF) energy to target and reduce hair follicles, enabling permanent or semi-permanent hair reduction through controlled thermal damage to the hair bulb. This modification builds upon the original Aurora DS design, maintaining its core function while enhancing energy output for improved efficacy. The device operates within dermatological settings, adhering to established safety protocols for skin treatment.
This modification is supplied as a reusable medical device intended for use in clinical or professional dermatology settings. The device requires proper training and adherence to manufacturer guidelines for safe operation, including skin preparation, energy settings, and post-treatment care. It is not sterile at shipment but may be cleaned and reprocessed per regulatory standards for reusable devices. The modification carries an FDA 510(k) clearance (K033586) under the Special 510(k) pathway, classified under product code GEX for General and Plastic Surgery applications, with a 14-day review period. Storage and handling follow standard medical device protocols to ensure functionality and patient safety.
Other devices from Syneron Medical Ltd
Questions
AI-generated answers, 1 Oct 2026
What is the Aurora DS Modification designed for?
The Aurora DS Modification is a laser hair removal device designed for permanent or semi-permanent hair reduction in dermatological settings. It uses selective thermolysis with optical and radiofrequency (RF) energy to target and damage hair follicles, reducing hair growth through controlled thermal effects on the hair bulb. This modification builds on the original Aurora DS design to improve efficacy by increasing energy output while maintaining safety standards for skin treatment.
How is the Aurora DS Modification supplied and intended for use?
The Aurora DS Modification is supplied as a reusable medical device, intended exclusively for professional or clinical dermatology settings. It requires proper operator training and strict adherence to manufacturer guidelines, including skin preparation, energy settings, and post-treatment care. Unlike single-use devices, it is not sterile at shipment but can be cleaned and reprocessed according to regulatory standards for reusable medical devices.
Is the Aurora DS Modification sterile upon delivery?
No, the Aurora DS Modification is not sterile at shipment. As a reusable device, it must be cleaned and reprocessed following established medical device reprocessing protocols to ensure safety and functionality before each use. Sterility is not applicable to reusable devices unless specified by the manufacturer for a specific procedure or setting.
What regulatory clearance does the Aurora DS Modification hold?
The Aurora DS Modification holds FDA 510(k) clearance under the Special 510(k) pathway, classified under product code GEX for General and Plastic Surgery. The clearance (K033586) was granted in 2003, with a decision described as substantially equivalent to a predicate device. This classification ensures the device meets regulatory standards for safety and effectiveness in its intended use.
How should the Aurora DS Modification be stored and handled?
The Aurora DS Modification must be stored and handled according to standard medical device protocols to maintain functionality and patient safety. This includes protecting the device from physical damage, contamination, and environmental factors like extreme temperatures or humidity. Follow manufacturer instructions for storage conditions, and ensure the device is properly cleaned and maintained between uses to prevent cross-contamination and ensure reliable performance.