FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COHERENT ULTRAPULSE CO2 SURGICAL LASERS
K Number: K963339
·
Decision Jan 22, 1997
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
27
Review Days
149
Basic Information
- Device Name
- COHERENT ULTRAPULSE CO2 SURGICAL LASERS
- K Number
- K963339
- 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
- August 26, 1996
- Decision Date
- January 22, 1997
- 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 |
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Other Clearances by COHERENT MEDICAL GROUP
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K932468 | NOVUS MULTIWAVELENGTH | Sep 22, 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 |