FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
K Number: K934706
·
Decision Apr 29, 1994
Classifications
1
FEI Numbers
476
Registration Numbers
479
Same Product Code
2793
Applicant Total
43
Review Days
211
Basic Information
- Device Name
- CANDELA PLTL-1 LASER SYSTEM: PIGMENTED LESION LASER AND TATULAZR
- K Number
- K934706
- 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
- CANDELA LASER CORP.
- Date Received
- September 30, 1993
- Decision Date
- April 29, 1994
- 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 CANDELA LASER CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K951033 | ANDELA DYNAMIC COOLING DEVICE | Aug 15, 1996 | Substantially Equivalent |
| K955662 | CANDELA Q-SWITCHED ALEXANDRITE LASERS | Jun 14, 1996 | Substantially Equivalent |
| K955011 | CANDELA HCS 2000 URETHERAL WARMER CATHETER | Apr 3, 1996 | Substantially Equivalent |
| K954872 | CANDELA CRYO-PROBE HOLDER | Feb 5, 1996 | Substantially Equivalent |
| K954934 | CANDELA SPTL LONG PULSE/TUNABLE PULSED DYE LASE | Feb 2, 1996 | Substantially Equivalent |
| K953412 | CANDELA MODEL PLTL-1 LASER SYSTEM | Oct 24, 1995 | Substantially Equivalent |
| K953294 | CANDELA CRYOSYSTEM CS-5 | Oct 18, 1995 | Substantially Equivalent |
| K950831 | ALEXLAZR | May 26, 1995 | Substantially Equivalent |
| K946386 | CANDELA RUBY LAZE Q-SWITCHED RUBY LASER | Mar 24, 1995 | Substantially Equivalent |
| K950661 | CANDELA 10MM CIRCULAR SPOT LASER HANDPIECE | Mar 10, 1995 | Substantially Equivalent |