FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
K Number: K180402
·
Decision May 25, 2018
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
6
Review Days
100
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Basic Information
- Device Name
- PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
- K Number
- K180402
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Topcon Medical Laser Systems, Inc.
- Date Received
- February 14, 2018
- Decision Date
- May 25, 2018
- Product Code
- HQF
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- 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 |
|---|---|---|---|
| HQF | Laser, Ophthalmic | FDA class 2 | Ophthalmic |
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Other Clearances by Topcon Medical Laser Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K171488 | PSLT for PASCAL Streamline | Nov 27, 2017 | Substantially Equivalent |
| K123542 | PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER | May 15, 2013 | Substantially Equivalent |
| K111108 | PASCAL STREAMLINE 577 (WITH ACCESSORIES) | Aug 11, 2011 | Substantially Equivalent |
| K092621 | PASCAL STREAMLINE PHOTOCOAGULATOR | Sep 25, 2009 | Substantially Equivalent |
| K043486 | PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 | Mar 3, 2005 | Substantially Equivalent |