FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
MODEL SLASE 210 HOLMIUM LASER SYSTEM
K Number: K920248
·
Decision Jul 21, 1992
Classifications
1
FEI Numbers
193
Registration Numbers
193
Same Product Code
86
Applicant Total
18
Review Days
182
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Basic Information
- Device Name
- MODEL SLASE 210 HOLMIUM LASER SYSTEM
- K Number
- K920248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.6740
- Medical Specialty
- General Hospital
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Sunrise Technologies, Inc.
- Date Received
- January 21, 1992
- Decision Date
- July 21, 1992
- Product Code
- GCX
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| GCX | Apparatus, Suction, Operating-Room, Wall Vacuum Powered | FDA class 2 | General Hospital |
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Other Clearances by Sunrise Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K962192 | SUNRISE CURING LAMP | Sep 3, 1996 | Substantially Equivalent |
| K942542 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Sep 1, 1994 | Substantially Equivalent |
| K932997 | MICROPREP CAVITY PREPERATION SYSTEM | Apr 25, 1994 | Substantially Equivalent |
| K933007 | SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMS | Jan 10, 1994 | Substantially Equivalent |
| K933017 | MODEL 5030 SUCTION HANDPIECE SYSTEM | Jul 26, 1993 | Substantially Equivalent |
| K931774 | UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASER | Jul 22, 1993 | Substantially Equivalent |
| K930789 | 8-WATT PULSED DENTAL LASER SYSTEM | May 21, 1993 | Substantially Equivalent |
| K930879 | 2.5 WATT PULSED DENTAL LASER SYSTEM | May 21, 1993 | Substantially Equivalent |
| K925549 | SLASE 210 PLUS HOLMIUM LASER SYSTEM | Mar 9, 1993 | Substantially Equivalent |
| K920107 | ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR | Mar 13, 1992 | Substantially Equivalent |