Zeltiq Aesthetics, Inc.: FDA filings under this applicant name

FDA lists 16 510(k) clearances under the applicant name “Zeltiq Aesthetics, Inc.” (first 2008, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 97 days. Since 2017 the median was 61 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Zeltiq Aesthetics, Inc. took a median 61 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.

Top product codes

Review panels

• General and Plastic Surgery (17)

Most recent Zeltiq Aesthetics, Inc. 510(k) clearances

6 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

6 product recalls in 2 recall events; 5 initiated in the last five years. Most recent: 2022-06-09.

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.

Device clinical trials

An industry sponsor named Zeltiq Aesthetics, Inc. is the lead sponsor of 36 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT05730335: A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device in Adult Participants for the Appearance of Cellulite (Completed, started 2023-02-07)
• NCT05664581: A Study to Assess the Adverse Events and Effectiveness of Rapid Acoustic Pulse (RAP) Device for the Appearance of Cellulite in Adult Participants (Completed, started 2022-12-14)
• NCT04876118: Effects on Cellulite Appearance (Completed, started 2020-11-13)
• NCT04506307: CoolSculpting System (Completed, started 2020-03-13)
• NCT04506502: Functional Change With MMS (Completed, started 2020-03-04)

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.

• Zeltiq Aesthetics, Inc. (Acquired by Allergan Aesthetics (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Zeltiq Aesthetics, Inc.?

FDA lists 16 510(k) clearances under the applicant name “Zeltiq Aesthetics, Inc.” (first 2008, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Zeltiq Aesthetics, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Zeltiq Aesthetics, Inc. is 97 days. Since 2017: 61 days, versus 90 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Zeltiq Aesthetics, Inc.?

The most frequent FDA product codes under this applicant name are OOK (Dermal Cooling Pack/Vacuum/Massager, 13); GEX (Powered Laser Surgical Instrument, 4).

Next steps

• See all 16 Zeltiq Aesthetics, Inc. clearances with predicates and recalls
• Run predicate analysis for product code OOK, Zeltiq Aesthetics, Inc.'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.

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