FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
K Number: K103547
·
Decision Nov 3, 2011
Classifications
1
FEI Numbers
60
Registration Numbers
61
Same Product Code
179
Applicant Total
9
Review Days
336
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Basic Information
- Device Name
- LIGHTLAS MULTI-WAVELENGTH MEDICAL LASER SYSTEM
- K Number
- K103547
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 886.4390
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lightmed Corp.
- Date Received
- December 2, 2010
- Decision Date
- November 3, 2011
- 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 Lightmed Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K142172 | LIGHTMED TRUSCAN 577 | Feb 27, 2015 | Substantially Equivalent |
| K124043 | LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM | Sep 26, 2013 | Substantially Equivalent |
| K091981 | LIGHTLAS 577 MEDICAL OPTICAL PUMPED SEMICONDUCTOR LASER | Sep 28, 2009 | Substantially Equivalent |
| K091534 | LIGHTLAS MODEL 532 | Sep 18, 2009 | Substantially Equivalent |
| K090774 | LIGHTLAS SELECTOR | Aug 13, 2009 | Substantially Equivalent |
| K063297 | LIGHTLAS 561 OPTHALMIC PHOTOCOAGULATOR | Sep 20, 2007 | Substantially Equivalent |
| K021538 | LIGHTLAS 810 INFRARED LASER PHOTOCOAGULATOR | Aug 8, 2002 | Substantially Equivalent |
| K010372 | LIGHTLAS 532 PHOTOCOAGULATOR | Aug 22, 2001 | Substantially Equivalent |