FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NOVUS MULTIWAVELENGTH
K Number: K932468
·
Decision Sep 22, 1993
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
27
Review Days
121
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- NOVUS MULTIWAVELENGTH
- K Number
- K932468
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Coherent Medical Group
- Date Received
- May 24, 1993
- Decision Date
- September 22, 1993
- Product Code
- GEX
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- SU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GEX | Powered Laser Surgical Instrument | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.
Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
PICOSURE WORKSTATION
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LumiGlam Laser System (SHE-LSP601-3)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LASEmaR 1500
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
LUNE PureHygiene
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Boston 2910 (Boston 2910)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Coherent Medical Group
| K Number | Device Name | ||
|---|---|---|---|
| K963339 | COHERENT ULTRAPULSE CO2 SURGICAL LASERS | Jan 22, 1997 | Substantially Equivalent |
| K960032 | COHERENT VERSAPULSE AESTHETIC SURGICAL LASERS | Apr 1, 1996 | Substantially Equivalent |
| K932981 | COHERENT VERSAPULSE 2.1 HOLMIUM SURGICAL LASERS | May 2, 1994 | Substantially Equivalent |
| K923575 | COHERENT VERSAPLUSE 2.1 HOLMIUM SURG. LASERS | Sep 29, 1993 | Substantially Equivalent |
| K930981 | ACCULITE(TM) OTOPROBE | Jul 28, 1993 | Substantially Equivalent |
| K914136 | COHERENT VERSAPULSE(TM) 2.1XE/2.1L HOLMI SURG LASE | Jul 21, 1992 | Substantially Equivalent |
| K914991 | VERSAPULSE(TM) TWOPOINTONE/XE HOLMIUM SURG LASERS | May 6, 1992 | Substantially Equivalent |
| K913127 | COHERENT NOVUS 3000 ARGON PHOTOCOAGULATOR | Oct 8, 1991 | Substantially Equivalent |
| K910037 | COHERENT HOLMIUM:YAG SURGICAL LASER | Sep 25, 1991 | Substantially Equivalent |
| K912029 | ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER | Aug 13, 1991 | Substantially Equivalent |