TRILASE 2940 ERBIUM LASER— 510(k) K954013
Substantially EquivalentSchwartz Electro-Optics, Inc.
FDA 510(k) clearance K954013 for TRILASE 2940 ERBIUM LASER, Substantially Equivalent on 1996-01-31. Applicant: Schwartz Electro-Optics, Inc.. Device class: 2.
Clearance details
- Applicant
- Schwartz Electro-Optics, 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
- Orlando, FL, US
Recent devices under product code GEX
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view all- K980710 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 DP ALEXANDRITE LASER SYSTEM
- K980313 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
- K973867 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM
- K974039 — SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
- K973603 — SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
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.