FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AURORA HL
K Number: K992374
·
Decision Sep 22, 1999
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
14
Review Days
69
Basic Information
- Device Name
- AURORA HL
- K Number
- K992374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4810
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- PREMIER LASER SYSTEMS, INC.
- Date Received
- July 15, 1999
- Decision Date
- September 22, 1999
- 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 PREMIER LASER SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K993285 | AURORA SL | Nov 18, 1999 | Substantially Equivalent |
| K992620 | BLULAZE | Aug 20, 1999 | Substantially Equivalent |
| K981379 | AURORA | Nov 23, 1998 | Substantially Equivalent |
| K983211 | CENTAURI | Oct 9, 1998 | Substantially Equivalent |
| K980559 | PEGASUS ND:YAG LASER SYSTEM | Aug 24, 1998 | Substantially Equivalent |
| K974586 | AURORA DIODE LASER SYSTEM | Jul 15, 1998 | Substantially Equivalent |
| K980561 | DERMIUM | Mar 19, 1998 | Substantially Equivalent |
| K971118 | ARAGO | Dec 16, 1997 | Substantially Equivalent |
| K933841 | CENTAURI | May 5, 1997 | Substantially Equivalent |
| K932683 | CENTAURI | May 5, 1997 | Substantially Equivalent |