Tiger Aesthetics Medical, LLC: FDA filings under this applicant name
FDA lists 0 510(k) clearances under the applicant name “Tiger Aesthetics Medical, LLC”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | 1 | 0 |
| LMH | Implant, Dermal, For Aesthetic Use | 1 | 0 |
Review panels
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P070004 | PMA | SIENTRA SILICONE GEL BREAST IMPLANTS | 2012-03-09 |
| P020012 | PMA | ARTEFILL, BELLAFILL PMMA COLLAGEN PERMANENT DERMAL FILLER | 2006-10-27 |
Recalls
openFDA lists no recalls under a recalling firm named Tiger Aesthetics Medical, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Tiger Aesthetics Medical, LLC (a text match, not an official crosswalk):
- L8616 — Microphone for use with cochlear implant device, replacement (via LMH)
- L8615 — Headset/headpiece for use with cochlear implant device, replacement (via LMH)
- L8617 — Transmitting coil for use with cochlear implant device, replacement (via LMH)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Tiger Medical Products, Ltd. (6 510(k)s)
- Tiger Electronics, Inc. (1 510(k)s)
- Tiger Marketing, Inc. (1 510(k)s)
- Tiger Meditech Incorporated (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Tiger Aesthetics Medical, LLC?
FDA lists 0 510(k) clearances under the applicant name “Tiger Aesthetics Medical, LLC”, plus 2 PMA decisions, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
Which FDA product codes appear under Tiger Aesthetics Medical, LLC?
The most frequent FDA product codes under this applicant name are FTR (Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled, 1); LMH (Implant, Dermal, For Aesthetic Use, 1).
Next steps
- See all 0 Tiger Aesthetics Medical, LLC clearances with predicates and recalls
- Run predicate analysis for product code FTR, Tiger Aesthetics Medical, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.