FRAXEL SR LASER SYSTEM— 510(k) K050841
Substantially EquivalentReliant Technologies, Inc.
FDA 510(k) clearance K050841 for FRAXEL SR LASER SYSTEM, Substantially Equivalent on 2005-07-05. Applicant: Reliant Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Reliant Technologies, Inc.
- Product code
- Code GEX
- Device class
- Class 2
- Regulation
- 21 CFR 878.4810
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palo Alto, CA, US
Recent devices under product code GEX
view allMore clearances from Reliant Technologies, Inc.
view all- K080915 — FRAXEL RE:PAIR (FRAXEL III SR) LASER SYSTEM AND ACCESSORIES
- K071051 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES
- K071621 — RELIANT TECHNOLOGIES C300 CHILLER SYSTEM AND ACCESSORIES
- K070284 — FRALEX SR 1500 LASER SYSTEM (FRALEX II SR LASER SYSTEM)
- K063038 — FRAXEL III SR LASER SYSTEM AND ACCESSORIES
Adverse events under product code GEX
product code GEX- Death
- 33
- Injury
- 3,045
- Malfunction
- 12,903
- Other
- 25
- Total
- 16,006
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.