FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL
K Number: K900539
·
Decision May 3, 1990
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
18
Review Days
87
Basic Information
- Device Name
- MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORAL
- K Number
- K900539
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- SUNRISE TECHNOLOGIES, INC.
- Date Received
- February 5, 1990
- Decision Date
- May 3, 1990
- 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 |
| 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 |
| K930879 | 2.5 WATT PULSED DENTAL LASER SYSTEM | May 21, 1993 | Substantially Equivalent |
| K930789 | 8-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 |