FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 5030 SUCTION HANDPIECE SYSTEM
K Number: K933017
·
Decision Jul 26, 1993
Classifications
1
FEI Numbers
478
Registration Numbers
480
Same Product Code
2867
Applicant Total
18
Review Days
35
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Basic Information
- Device Name
- MODEL 5030 SUCTION HANDPIECE SYSTEM
- K Number
- K933017
- 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
- Sunrise Technologies, Inc.
- Date Received
- June 21, 1993
- Decision Date
- July 26, 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 |
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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 |
| 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 |
| K920248 | MODEL SLASE 210 HOLMIUM LASER SYSTEM | Jul 21, 1992 | Unknown |
| K920107 | ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SUR | Mar 13, 1992 | Substantially Equivalent |