MICROSURGICAL CO2 LASER SYS - 4100— 510(k) K840406
Substantially EquivalentBio Quantum Technologies, Inc.
FDA 510(k) clearance K840406 for MICROSURGICAL CO2 LASER SYS - 4100, Substantially Equivalent on 1984-08-20. Applicant: Bio Quantum Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Bio Quantum 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
- Walker, MI, US
Recent devices under product code GEX
view allMore clearances from Bio Quantum Technologies, Inc.
view all- K934089 — BIO QUANTUM TECHNOLOGIES, INC. HAND-HELD CO2 LASER SYSTEM MODEL HH-550S
- K864946 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
- K864887 — ADVANCED HAND HELD CO2 LASER MODEL HH-550 FOR SU
- K864948 — ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
- K837110 — MODEL 4100 MICROSURGICAL CO2 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.