FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERFECT SUNTANNING BED
K Number: K873589
·
Decision Oct 29, 1987
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
80
Applicant Total
2
Review Days
55
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
- PERFECT SUNTANNING BED
- K Number
- K873589
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 878.4635
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- Wolff System Technology Corp.
- Date Received
- September 4, 1987
- Decision Date
- October 29, 1987
- Product Code
- LEJ
- 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 |
|---|---|---|---|
| LEJ | Booth, Sun Tan | FDA class 2 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LEJ), ordered by most recent decision date.
Tanning Lamp
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ergoline Vitality Total Light 3, Planet Fitness 50/4 TLT by Ergoline, Planet Fitness 42/3 TLT by Ergoline, Ergoline Vitality Hybrid Light 3, Ergoline Vitality Hybrid Light, Planet Fitness 50/4 HLT by Ergoline, Planet Fitness 46/3 HLT by Ergoline, Ergoline Vitality Pure Light 3, Ergoline Vitality Pure Light, Planet Fitness 50/4 PLT III by Ergoline, Planet Fitness 50/4 PLT by Ergoline, Planet Fitness 46/3 PLT by Ergoline, Planet Fitness 42/3 PLT by Ergoline
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
KBL 7000 alpha hybridSun, KBL 7900 alpha hybridSun, KBL 8000 alpha hybridSun
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ergoline Inspiration 550 Hybrid Technology / Sound, Ergoline Inspiration 550 Hybrid Technology / AC / Sound, Ergoline Planet Fitness 42/4 Hybrid Light Technology / Sound
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ergoline Sunrise 7200 Hybrid Technology
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Ergoline Prestige 1600 Hybrid Performance
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Other Clearances by Wolff System Technology Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K151841 | Ultraviolet Sunlamps | Oct 5, 2015 | Substantially Equivalent |