FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
K Number: K011960
·
Decision Dec 21, 2001
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
8
Review Days
182
Basic Information
- Device Name
- LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS POCKETPRO OR POCKETPRO S4)
- K Number
- K011960
- 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
- LARES RESEARCH, INC.
- Date Received
- June 22, 2001
- Decision Date
- December 21, 2001
- 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 LARES RESEARCH, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K141221 | LARES ULTRALITE PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES EURO PROSTYLE HIGH-SPEED DENTAL HANDPIECES, LARES TURBO+ PR | Oct 28, 2014 | Substantially Equivalent |
| K031540 | APEX ELECTRIC HANDPIECE SYSTEM | Jun 30, 2003 | Substantially Equivalent |
| K983524 | LARES RESEARCH SUNLASE 800P LASER SYSTEM (TO BE SOLD AS PEIOLASE FOR LASERENAP) | Apr 1, 1999 | Substantially Equivalent |
| K961163 | LARES RESEARCH AS-1 LOWSPEED HANDPIECE | Apr 23, 1996 | Substantially Equivalent |
| K905543 | LARES APOLLO CS/CP/C | Mar 11, 1991 | Substantially Equivalent |
| K905542 | LARES APOLLO CS AND S HANDPIECE LIGHTING SYSTEMS | Mar 11, 1991 | Substantially Equivalent |
| K905541 | LARES 757 WORKHORSE HIGHSPEED HANDPIECE | Mar 7, 1991 | Substantially Equivalent |