FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WS-501 HEAT LAMP
K Number: K013197
·
Decision Aug 29, 2002
Classifications
1
FEI Numbers
462
Registration Numbers
462
Same Product Code
228
Applicant Total
11
Review Days
338
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- WS-501 HEAT LAMP
- K Number
- K013197
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5500
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lhasa Medical, Inc.
- Date Received
- September 25, 2001
- Decision Date
- August 29, 2002
- Product Code
- ILY
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| ILY | Lamp, Infrared, Therapeutic Heating | FDA class 2 | Physical Medicine |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ILY), ordered by most recent decision date.
CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)
FDA 510(k)
FDA Class 2
·Physical Medicine
Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)
FDA 510(k)
FDA Class 2
·Physical Medicine
SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)
FDA 510(k)
FDA Class 2
·Physical Medicine
LED Lip Perfector, model: ZC-05
FDA 510(k)
FDA Class 2
·Physical Medicine
OLIZ LTB-1000A
FDA 510(k)
FDA Class 2
·Physical Medicine
CytonPro-5000
FDA 510(k)
FDA Class 2
·Physical Medicine
Other Clearances by Lhasa Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031250 | DBC PRESS ACUPUNCTURE NEEDLES | Jul 15, 2003 | Substantially Equivalent |
| K031060 | NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES | Jul 11, 2003 | Substantially Equivalent |
| K023787 | TAI-CHI AND MASTER ACUPUNCTURE NEEDLES | Feb 14, 2003 | Substantially Equivalent |
| K003538 | TDP CQ-27 HEAT LAMP | Jun 4, 2001 | Substantially Equivalent |
| K003760 | TAI-CHI ACUPUNCTURE NEEDLES | Feb 6, 2001 | Substantially Equivalent |
| K964529 | CW ACUPUNCTURE NEEDLES | Jan 30, 1997 | Substantially Equivalent |
| K964411 | TAKI ACUPUNCTURE NEEDLES | Dec 31, 1996 | Substantially Equivalent |
| K963299 | HWA-TO ACUPUNCTURE NEEDLES | Sep 30, 1996 | Substantially Equivalent |
| K963300 | DBC ACUPUNTURE NEEDLES(SEVERAL TYPES ARE DESCRIBED ON THE FOLLOWING PAGES) | Sep 23, 1996 | Substantially Equivalent |
| K962916 | HUA-XIA ACUPUNCTURE NEEDLES | Aug 23, 1996 | Substantially Equivalent |